82_FR_44810 82 FR 44626 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

82 FR 44626 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 184 (September 25, 2017)

Page Range44626-44628
FR Document2017-20391

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Dockets Management Staff.

Federal Register, Volume 82 Issue 184 (Monday, September 25, 2017) 
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44626-44628]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-
2016-M-1916, FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-
2016-M-2183, FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-
2016-M-2334, FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-
2016-M-2499, FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-
2016-M-2651, FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-
2016-M-1972, FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-
2016-M-3431, FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-
2016-M-3915, FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-
2016-M-4459, FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-
2016-M-4653, FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-
2017-M-0560, FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-
2017-M-2652, FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-
2017-M-1845, FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-
2017-M-1950, FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-
2017-M-2768, FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-
2017-M-3579, FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-
2017-M-3928, FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
premarket approval applications (PMAs) that have been approved. This 
list is intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
Agency's Dockets Management Staff.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-2016-M-1916, 
FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-2016-M-2183, 
FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-2016-M-2334, 
FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-2016-M-2499, 
FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-2016-M-2651, 
FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-2016-M-1972, 
FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-2016-M-3431, 
FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-2016-M-3915, 
FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-2016-M-4459, 
FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-2016-M-4653, 
FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-2017-M-0560, 
FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-2017-M-2652, 
FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-2017-M-1845, 
FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-2017-M-1950, 
FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-2017-M-2768, 
FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-2017-M-3579, 
FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-2017-M-3928, 
FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983 for ``Medical 
Devices; Availability of Safety and Effectiveness Summaries for 
Premarket Approval Applications.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

[[Page 44627]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the FD&C Act. The 
30-day period for requesting reconsideration of an FDA action under 
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a 
PMA begins on the day the notice is placed on the internet. Section 
10.33(b) provides that FDA may, for good cause, extend this 30-day 
period. Reconsideration of a denial or withdrawal of approval of a PMA 
may be sought only by the applicant; in these cases, the 30-day period 
will begin when the applicant is notified by FDA in writing of its 
decision.
    The regulations provide that FDA publish a quarterly list of 
available safety and effectiveness summaries of PMA approvals and 
denials that were announced during that quarter. The following is a 
list of approved PMAs for which summaries of safety and effectiveness 
were placed on the internet from July 1, 2016, through June 30, 2017. 
There were no denial actions during this period. The list provides the 
manufacturer's name, the product's generic name or the trade name, and 
the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2016 Through
                                                  June 30, 2017
----------------------------------------------------------------------------------------------------------------
                                                                                                       Approval
          PMA No., Docket No.                     Applicant                    Trade name                date
----------------------------------------------------------------------------------------------------------------
P130018, FDA-2015-M-4474...............  Uromedica, Inc............  ProACTTM Adjustable Continence     11/24/15
                                                                      Therapy for Men.
P140003/S004, FDA-2016-M-1915..........  Abiomed, Inc..............  Impella Ventricular Support...     4/7/2016
P150034, FDA-2016-M-1837...............  Revision Optics, Inc......  Raindrop Near Vision Inlay....    6/29/2016
P150017, FDA-2016-M-1916...............  Cartiva, Inc..............  Cartiva Synthetic Cartilage        7/1/2016
                                                                      Implant.
P150023, FDA-2016-M-1914...............  Abbott Vascular...........  Absorb GT1TM Bioresorbable         7/5/2016
                                                                      Vascular Scaffold (BVS)
                                                                      System.
P100020/S017, FDA-2016-M-1917..........  Roche Molecular Systems,    cobas[supreg] HPV Test........     7/7/2016
                                          Inc.
P090029/S003, FDA-2016-M-2182..........  Medtronic Sofamor Danek     Prestige LPTM Cervical Disc...     7/7/2016
                                          USA, Inc.
P150038, FDA-2016-M-2183...............  InSightec, Inc............  ExAblate Model 4000 Type 1.0      7/11/2016
                                                                      System (ExAblate Neuro).
P980040/S065, FDA-2016-M-2184..........  Abbott Medical Optics, Inc  TECNIS[supreg] Symfony            7/15/2016
                                                                      Extended Range of Vision
                                                                      Intraocular Lens.
P150006, FDA-2016-M-2185...............  Vasorum, Ltd..............  Celt ACD Vascular Closure         7/20/2016
                                                                      Device.
P160004, FDA-2016-M-2332...............  W.L. Gore & Associates,     Gore TIGRIS Vascular Stent....    7/27/2016
                                          Inc.
P150003/S003, FDA-2016-M-2334..........  Boston Scientific Corp....  SYNERGYTM Everolimus-Eluting      7/29/2016
                                                                      Platinum Chromium Coronary
                                                                      Stent System (Over-The-Wire &
                                                                      Monorail).
P150037, FDA-2016-M-2333...............  Alcon Laboratories, Inc...  CyPass[supreg] System (Model      7/29/2016
                                                                      241-S).
P150001, FDA-2016-M-2500...............  Medtronic MiniMed.........  MiniMed 630G System with          8/10/2016
                                                                      SmartGuard.
P150036, FDA-2016-M-2485...............  Edwards Lifesciences, LLC.  Edwards INTUITY Elite Valve       8/12/2016
                                                                      System.
P130009/S057, FDA-2016-M-2498..........  Edwards Lifesciences LLC..  Edwards SAPIEN XT                 8/18/2016
                                                                      Transcatheter Heart Valve.
P140031/S010, FDA-2016-M-2499..........  Edwards Lifesciences LLC..  Edwards SAPIEN 3 Transcatheter    8/18/2016
                                                                      Heart Valve.
P020045/S073, 2016-M-2649..............  Medtronic, Inc............  Freezor[supreg] Xtra Cardiac      8/31/2016
                                                                      Cryoablation Catheter.
P140010/S015, FDA-2016-M-2650..........  Medtronic Vascular, Inc...  In PactTM AdmiralTM Paclitaxel-    9/7/2016
                                                                      Coated Percutaneous
                                                                      Transluminal Angioplasty
                                                                      Balloon Catheter.
P160001, FDA-2016-M-2651...............  Obalon Therapeutics, Inc..  Obalon Balloon System.........     9/8/2016
P150040, FDA-2016-M-2735...............  Carl Zeiss Meditec, Inc...  VisuMax[supreg] Femtosecond       9/13/2016
                                                                      Laser.
P000025/S084, FDA-2016-M-2974..........  MED-EL Corp...............  MED-EL Cochlear Implant System    9/15/2016
P150021, FDA-2016-M-2971...............  Abbott Diabetes Care, Inc.  Freestyle Libre Pro Flash         9/23/2016
                                                                      Glucose Monitoring System.
P080020/S020, FDA-2016-M-2975..........  Seikagaku Corp............  Gel-One[supreg]...............    9/27/2016
P160017, FDA-2016-M-1972...............  Medtronic MiniMed, Inc....  MiniMed 670G System...........    9/28/2016
P150044, FDA-2016-M-2973...............  Roche Molecular Systems,    cobas[supreg] EGFR Mutation       9/28/2016
                                          Inc.                        Test v2.
P150030, FDA-2016-M-3430...............  Smith & Nephew, Inc.......  R3TM delta Ceramic Acetabular    10/17/2016
                                                                      System.
P160006, FDA-2016-M-3431...............  Ventana Medical Systems,    VENTANA PD-L1 (SP142) Assay...   10/18/2016
                                          Inc.
P150013/S001, FDA-2016-M-3913..........  Dako North America, Inc...  PD-L1 IHC 22C3 pharmDX........   10/24/2016
P120021, FDA-2016-M-3653...............  St. Jude Medical, Inc.....  AmplatzerTM PFO Occluder......   10/28/2016
P150043, FDA-2016-M-3914...............  QView Medical, Inc........  QVCAD System..................    11/9/2016
P930016/S045, FDA-2016-M-3915..........  AMO Manufacturing USA, LLC  Star S4 IR Excimer Laser         11/14/2016
                                                                      System and iDesign Advanced
                                                                      WaveScan Studio.
P020050/S023, FDA-2016-M-4046..........  Alcon Laboratories, Inc...  WaveLight[supreg] EX500 and      11/21/2016
                                                                      ALLEGRETTO WAVE[supreg] EYE-Q
                                                                      Excimer Laser Systems.
P140029, FDA-2016-M-4344...............  Q-Med AB..................  Restylane[supreg] Refyne and      12/9/2016
                                                                      Restylane[supreg] Defyne.
P130007/S016, FDA-2016-M-4458..........  Animas Corporation........  OneTouch VibeTM Plus System...   12/16/2016
P160018, FDA-2016-M-4459...............  Foundation Medicine, Inc..  FoundationFocusTM CDxBRACA       12/19/2016
                                                                      Assay.
P120005/S041, FDA-2016-M-4483..........  Dexcom, Inc...............  Dexcom G5 Mobile Continuous      12/20/2016
                                                                      Glucose Monitoring System.
P040020/S049, FDA-2016-M-4657..........  Alcon Laboratories, Inc...  Acrysof[supreg] IQ               12/22/2016
                                                                      ReSTOR[supreg] +3.0 D
                                                                      Multifocal Toric Intraocular
                                                                      Lens.
P160019, FDA-2016-M-4530...............  Roche Diagnostics.........  Elecsys HBsAg II/Elecsys HBsAg   12/23/2016
                                                                      Confirmatory Test/
                                                                      PreciControl HBsAg II.
P100022/S020, FDA-2016-M-4653..........  Cook Medical Inc..........  Zilver PTX Drug-Eluting          12/28/2016
                                                                      Peripheral Stent.
H070005, FDA-2017-M-0180...............  AGA Medical Corp..........  AMPLATZERTM Post-Infarct          1/10/2017
                                                                      Muscular VSD Occluder.
P160031, FDA-2017-M-0181...............  FUJIFILM Medical Systems    ASPIRE Cristalle Digital          1/10/2017
                                          U.S.A., Inc.                Breast Tomosynthesis Option.
P160008, FDA-2017-M-0229...............  HeartSine Technologies LLC  HeartSine samaritan[supreg]       1/12/2017
                                                                      SAM 350P, SAM 360P, and SAM
                                                                      450P Public Access Automated
                                                                      External Defibrillators,
                                                                      Accessories and Saver
                                                                      EVO[supreg] Software Version
                                                                      1.4.0.
P160021, FDA-2017-M-0560...............  W.L. Gore & Associates,     Gore[supreg] Viabahn[supreg]      1/27/2017
                                          Inc.                        VBX Balloon Expandable
                                                                      Endoprosthesis.
P130024/S009, FDA-2017-M-0831..........  Lutonix, Inc..............  Lutonix[supreg] 035 Drug           2/7/2017
                                                                      Coated Balloon PTA Catheter.
P140033, FDA-2017-M-0661...............  St. Jude Medical, Inc.....  MR Conditional Pacemaker          1/31/2017
                                                                      System--Assurity MRITM and
                                                                      Endurity MRITM Pacemakers and
                                                                      Tendril MRITM 1200M LPA Lead.
P160023, FDA-2017-M-0971...............  Hologic, Inc..............  Aptima[supreg] HCV Quant Dx       2/13/2017
                                                                      Assay.

[[Page 44628]]

 
P160003, FDA-2016-M-2652...............  Biotronik, Inc............  PRO-Kinetic Energy Cobalt         2/14/2017
                                                                      Chromium Coronary Stent
                                                                      System.
P150039, FDA-2017-M-1121...............  Tryton Medical, Inc.......  TRYTON Side Branch Stent......    2/21/2017
P160014, FDA-2017-M-1122...............  CeloNova BioSciences, Inc.  COBRA PzFTM NanoCoated            2/21/2017
                                                                      Coronary Stent System.
P100044/S023, FDA-2017-M-1228..........  Intersect ENT.............  PROPEL[supreg] Contour Sinus      2/23/2017
                                                                      Implant.
P140017/S005, FDA-2017-M-1227..........  Medtronic, Inc............  MelodyTM Transcatheter            2/24/2017
                                                                      Pulmonary Valve, EnsembleTM
                                                                      Transcatheter Valve Delivery
                                                                      System and EnsembleTM II
                                                                      Transcatheter Valve Delivery
                                                                      System.
P160016, FDA-2017-M-1713...............  Siemens Healthcare          VERSANT[supreg] HCV GENOTYPE      3/14/2017
                                          Diagnostics, Inc.           2.0 Assay (LiPA).
P110033/S020, FDA-2017-M-1714..........  Allergan..................  Juv[eacute]derm VollureTM XC..    3/17/2017
P160025, FDA-2017-M-1845...............  Biotronik, Inc............  Astron Pulsar and Pulsar-18       3/23/2017
                                                                      Stent Systems.
P160009, FDA-2017-M-1950...............  iCAD, Inc.................  PowerLook[supreg] Tomo            3/24/2017
                                                                      Detection Software.
P160024, FDA-2017-M-2594...............  Bard Peripheral Vascular,   LifeStream Balloon Expandable     4/24/2017
                                          Inc.                        Vascular Covered Stent.
P160043, FDA-2017-M-2767...............  Medtronic, Inc............  Resolute Onyx Zotarolimus-        4/28/2017
                                                                      Eluting Coronary Stent System.
P160040, FDA-2017-M-2766...............  Invivoscribe Technologies,  LeukoStrat[supreg] CDx FLT3       4/28/2017
                                          Inc.                        Mutation Assay.
P160046, FDA-2017-M-2768...............  Ventana Medical Systems,    VENTANA PD-L1 (SP263) Assay...     5/1/2017
                                          Inc.
H150003, FDA-2017-M-3103...............  Wilson-Cook Medical, Inc..  FlourishTM Pediatric              5/12/2017
                                                                      Esophageal Atresia Device.
P160044, FDA-2017-M-3200...............  Abbott Molecular, Inc.....  Abbott RealTime CMV...........    5/18/2017
P160041, FDA-2017-M-3430...............  Roche Molecular Systems,    cobas[supreg] CMV.............     6/1/2017
                                          Inc.
P140031/S028, FDA-2017-M-3579..........  Edwards Lifesciences LLC..  Edwards SAPIEN 3TM                 6/5/2017
                                                                      Transcatheter Heart Valve and
                                                                      Accessories.
P160035, FDA-2017-M-3580...............  Berlin Heart, Inc.........  EXCOR[supreg] Pediatric            6/6/2017
                                                                      Ventricular Assist Device.
P160047, FDA-2017-M-3778...............  AEGEA Medical, Inc........  AEGEA Vapor SystemTM..........    6/14/2017
H160002, FDA-2017-M-3839...............  Pulsar Vascular, Inc......  PulseRider[supreg] Aneurysm       6/19/2017
                                                                      Neck Reconstruction Device
                                                                      (``PulseRider'').
P160045, FDA-2017-M-3928...............  Life Technologies Corp....  OncomineTM Dx Target Test.....    6/22/2017
P150046, FDA-2017-M-3982...............  SciBase AB................  Nevisense.....................    6/28/2017
P150048, FDA-2017-M-3990...............  Edwards Lifesciences, LLC.  Edwards Pericardial Aortic        6/29/2017
                                                                      Bioprosthesis and Edwards
                                                                      INSPIRIS RESILIA Aortic Valve.
P160038, FDA-2017-M-3983...............  Illumina, Inc.............  PraxisTM Extended RAS Panel...    6/29/2017
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20391 Filed 9-22-17; 8:45 am]
 BILLING CODE 4164-01-P

44626 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices Dated: September 19, 2017. • Federal eRulemaking Portal: M–0180, FDA–2017–M–0181, FDA– Anna K. Abram, https://www.regulations.gov. Follow the 2017–M–0229, FDA–2017–M–0560, Deputy Commissioner for Policy, Planning, instructions for submitting comments. FDA–2017–M–0831, FDA–2017–M– Legislation, and Analysis. Comments submitted electronically, 0661, FDA–2017–M–0971, FDA–2017– [FR Doc. 2017–20375 Filed 9–22–17; 8:45 am] including attachments, to https:// M–2652, FDA–2017–M–1121, FDA– BILLING CODE 4164–01–P www.regulations.gov will be posted to 2017–M–1122, FDA–2017–M–1228, the docket unchanged. Because your FDA–2017–M–1845, FDA–2017–M– comment will be made public, you are 1227, FDA–2017–M–1713, FDA–2017– DEPARTMENT OF HEALTH AND solely responsible for ensuring that your M–1714, FDA–2017–M–1950, FDA– HUMAN SERVICES comment does not include any 2017–M–2594, FDA–2017–M–2766, confidential information that you or a FDA–2017–M–2767, FDA–2017–M– Food and Drug Administration third party may not wish to be posted, 2768, FDA–2017–M–3103, FDA–2017– [Docket Nos. FDA–2015–M–4474, FDA– such as medical information, your or M–3200, FDA–2017–M–3430, FDA– 2016–M–1915, FDA–2016–M–1837, FDA– anyone else’s Social Security number, or 2017–M–3579, FDA–2017–M–3580, 2016–M–1916, FDA–2016–M–1914, FDA– confidential business information, such FDA–2017–M–3778, FDA–2017–M– 2016–M–1917, FDA–2016–M–2182, FDA– as a manufacturing process. Please note 3839, FDA–2017–M–3928, FDA–2017– 2016–M–2183, FDA–2016–M–2184, FDA– that if you include your name, contact M–3982, FDA–2017–M–3990, and FDA– 2016–M–2185, FDA–2016–M–2332, FDA– information, or other information that 2017–M–3983 for ‘‘Medical Devices; 2016–M–2334, FDA–2016–M–2333, FDA– identifies you in the body of your Availability of Safety and Effectiveness 2016–M–2485, FDA–2016–M–2498, FDA– comments, that information will be Summaries for Premarket Approval 2016–M–2499, FDA–2016–M–2500, FDA– posted on https://www.regulations.gov. Applications.’’ Received comments will 2016–M–2649, FDA–2016–M–2650, FDA– • If you want to submit a comment be placed in the docket and, except for 2016–M–2651, FDA–2016–M–2735, FDA– with confidential information that you those submitted as ‘‘Confidential 2016–M–2974, FDA–2016–M–2971, FDA– 2016–M–1972, FDA–2016–M–2973, FDA– do not wish to be made available to the Submissions,’’ publicly viewable at 2016–M–2975, FDA–2016–M–3430, FDA– public, submit the comment as a https://www.regulations.gov or at the 2016–M–3431, FDA–2016–M–3913, FDA– written/paper submission and in the Dockets Management Staff between 9 2016–M–3653, FDA–2016–M–3914, FDA– manner detailed (see ‘‘Written/Paper a.m. and 4 p.m., Monday through 2016–M–3915, FDA–2016–M–4046, FDA– Submissions’’ and ‘‘Instructions’’). Friday. 2016–M–4344, FDA–2016–M–4458, FDA– • Confidential Submissions—To 2016–M–4459, FDA–2016–M–4483, FDA– Written/Paper Submissions submit a comment with confidential 2016–M–4657, FDA–2016–M–4530, FDA– Submit written/paper submissions as information that you do not wish to be 2016–M–4653, FDA–2017–M–0180, FDA– follows: made publicly available, submit your 2017–M–0181, FDA–2017–M–0229, FDA– • Mail/Hand delivery/Courier (for comments only as a written/paper 2017–M–0560, FDA–2017–M–0831, FDA– written/paper submissions): Dockets 2017–M–0661, FDA–2017–M–0971, FDA– submission. You should submit two Management Staff (HFA–305), Food and copies total. One copy will include the 2017–M–2652, FDA–2017–M–1121, FDA– 2017–M–1122, FDA–2017–M–1228, FDA– Drug Administration, 5630 Fishers information you claim to be confidential 2017–M–1845, FDA–2017–M–1227, FDA– Lane, Rm. 1061, Rockville, MD 20852. with a heading or cover note that states 2017–M–1713, FDA–2017–M–1714, FDA– • For written/paper comments ‘‘THIS DOCUMENT CONTAINS 2017–M–1950, FDA–2017–M–2594, FDA– submitted to the Dockets Management CONFIDENTIAL INFORMATION.’’ The 2017–M–2766, FDA–2017–M–2767, FDA– Staff, FDA will post your comment, as Agency will review this copy, including 2017–M–2768, FDA–2017–M–3103, FDA– well as any attachments, except for the claimed confidential information, in 2017–M–3200, FDA–2017–M–3430, FDA– information submitted, marked and its consideration of comments. The 2017–M–3579, FDA–2017–M–3580, FDA– identified, as confidential, if submitted second copy, which will have the 2017–M–3778, FDA–2017–M–3839, FDA– as detailed in ‘‘Instructions.’’ 2017–M–3928, FDA–2017–M–3982, FDA– claimed confidential information Instructions: All submissions received redacted/blacked out, will be available 2017–M–3990, and FDA–2017–M–3983] must include the Docket Nos. FDA– for public viewing and posted on Medical Devices; Availability of Safety 2015–M–4474, FDA–2016–M–1915, https://www.regulations.gov. Submit and Effectiveness Summaries for FDA–2016–M–1837, FDA–2016–M– both copies to the Dockets Management Premarket Approval Applications 1916, FDA–2016–M–1914, FDA–2016– Staff. If you do not wish your name and M–1917, FDA–2016–M–2182, FDA– contact information to be made publicly AGENCY: Food and Drug Administration, 2016–M–2183, FDA–2016–M–2184, available, you can provide this HHS. FDA–2016–M–2185, FDA–2016–M– information on the cover sheet and not ACTION: Notice. 2332, FDA–2016–M–2334, FDA–2016– in the body of your comments and you M–2333, FDA–2016–M–2485, FDA– must identify this information as SUMMARY: The Food and Drug 2016–M–2498, FDA–2016–M–2499, ‘‘confidential.’’ Any information marked Administration (FDA) is publishing a FDA–2016–M–2500, FDA–2016–M– as ‘‘confidential’’ will not be disclosed list of premarket approval applications 2649, FDA–2016–M–2650, FDA–2016– except in accordance with 21 CFR 10.20 (PMAs) that have been approved. This M–2651, FDA–2016–M–2735, FDA– and other applicable disclosure law. For list is intended to inform the public of 2016–M–2974, FDA–2016–M–2971, more information about FDA’s posting the availability of safety and FDA–2016–M–1972, FDA–2016–M– of comments to public dockets, see 80 effectiveness summaries of approved asabaliauskas on DSKBBXCHB2PROD with NOTICES 2973, FDA–2016–M–2975, FDA–2016– FR 56469, September 18, 2015, or access PMAs through the Internet and the M–3430, FDA–2016–M–3431, FDA– the information at: https://www.gpo.gov/ Agency’s Dockets Management Staff. 2016–M–3913, FDA–2016–M–3653, fdsys/pkg/FR-2015-09-18/pdf/2015- ADDRESSES: You may submit comments FDA–2016–M–3914, FDA–2016–M– 23389.pdf. as follows: 3915, FDA–2016–M–4046, FDA–2016– Docket: For access to the docket to M–4344, FDA–2016–M–4458, FDA– read background documents or the Electronic Submissions 2016–M–4459, FDA–2016–M–4483, electronic and written/paper comments Submit electronic comments in the FDA–2016–M–4657, FDA–2016–M– received, go to https:// following way: 4530, FDA–2016–M–4653, FDA–2017– www.regulations.gov and insert the VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1

Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44627 docket number, found in brackets in the Cosmetic Act (the FD&C Act) (21 U.S.C. period will begin when the applicant is heading of this document, into the 360e(d)(4) and (e)(2)), notification of an notified by FDA in writing of its ‘‘Search’’ box and follow the prompts order approving, denying, or decision. and/or go to the Dockets Management withdrawing approval of a PMA will The regulations provide that FDA Staff, 5630 Fishers Lane, Rm. 1061, continue to include a notice of publish a quarterly list of available Rockville, MD 20852. opportunity to request review of the safety and effectiveness summaries of order under section 515(g) of the FD&C FOR FURTHER INFORMATION CONTACT: PMA approvals and denials that were Act. The 30-day period for requesting Joshua Nipper, Center for Devices and announced during that quarter. The reconsideration of an FDA action under Radiological Health, Food and Drug following is a list of approved PMAs for § 10.33(b) (21 CFR 10.33(b)) for notices Administration, 10903 New Hampshire which summaries of safety and announcing approval of a PMA begins Ave., Bldg. 66, Rm. 1650, Silver Spring, effectiveness were placed on the on the day the notice is placed on the MD 20993–0002, 301–796–6524. internet from July 1, 2016, through June internet. Section 10.33(b) provides that SUPPLEMENTARY INFORMATION: FDA may, for good cause, extend this 30, 2017. There were no denial actions 30-day period. Reconsideration of a during this period. The list provides the I. Background denial or withdrawal of approval of a manufacturer’s name, the product’s In accordance with section 515(d)(4) PMA may be sought only by the generic name or the trade name, and the and (e)(2) of the Federal Food, Drug, and applicant; in these cases, the 30-day approval date. TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2016 THROUGH JUNE 30, 2017 Approval PMA No., Docket No. Applicant Trade name date P130018, FDA–2015–M–4474 .......... Uromedica, Inc ................................. ProACTTM Adjustable Continence Therapy for Men .................................. 11/24/15 P140003/S004, FDA–2016–M–1915 Abiomed, Inc .................................... Impella Ventricular Support ........................................................................ 4/7/2016 P150034, FDA–2016–M–1837 .......... Revision Optics, Inc ......................... Raindrop Near Vision Inlay ........................................................................ 6/29/2016 P150017, FDA–2016–M–1916 .......... Cartiva, Inc ....................................... Cartiva Synthetic Cartilage Implant ............................................................ 7/1/2016 P150023, FDA–2016–M–1914 .......... Abbott Vascular ................................ Absorb GT1TM Bioresorbable Vascular Scaffold (BVS) System ............... 7/5/2016 P100020/S017, FDA–2016–M–1917 Roche Molecular Systems, Inc ........ cobas® HPV Test ....................................................................................... 7/7/2016 P090029/S003, FDA–2016–M–2182 Medtronic Sofamor Danek USA, Inc Prestige LPTM Cervical Disc ....................................................................... 7/7/2016 P150038, FDA–2016–M–2183 .......... InSightec, Inc ................................... ExAblate Model 4000 Type 1.0 System (ExAblate Neuro) ........................ 7/11/2016 P980040/S065, FDA–2016–M–2184 Abbott Medical Optics, Inc ............... TECNIS® Symfony Extended Range of Vision Intraocular Lens ............... 7/15/2016 P150006, FDA–2016–M–2185 .......... Vasorum, Ltd .................................... Celt ACD Vascular Closure Device ............................................................ 7/20/2016 P160004, FDA–2016–M–2332 .......... W.L. Gore & Associates, Inc ........... Gore TIGRIS Vascular Stent ...................................................................... 7/27/2016 P150003/S003, FDA–2016–M–2334 Boston Scientific Corp ..................... SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent 7/29/2016 System (Over-The-Wire & Monorail). P150037, FDA–2016–M–2333 .......... Alcon Laboratories, Inc .................... CyPass® System (Model 241–S) ............................................................... 7/29/2016 P150001, FDA–2016–M–2500 .......... Medtronic MiniMed ........................... MiniMed 630G System with SmartGuard ................................................... 8/10/2016 P150036, FDA–2016–M–2485 .......... Edwards Lifesciences, LLC ............. Edwards INTUITY Elite Valve System ....................................................... 8/12/2016 P130009/S057, FDA–2016–M–2498 Edwards Lifesciences LLC .............. Edwards SAPIEN XT Transcatheter Heart Valve ...................................... 8/18/2016 P140031/S010, FDA–2016–M–2499 Edwards Lifesciences LLC .............. Edwards SAPIEN 3 Transcatheter Heart Valve ......................................... 8/18/2016 P020045/S073, 2016–M–2649 .......... Medtronic, Inc .................................. Freezor® Xtra Cardiac Cryoablation Catheter ........................................... 8/31/2016 P140010/S015, FDA–2016–M–2650 Medtronic Vascular, Inc ................... In PactTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal 9/7/2016 Angioplasty Balloon Catheter. P160001, FDA–2016–M–2651 .......... Obalon Therapeutics, Inc ................. Obalon Balloon System .............................................................................. 9/8/2016 P150040, FDA–2016–M–2735 .......... Carl Zeiss Meditec, Inc .................... VisuMax® Femtosecond Laser ................................................................... 9/13/2016 P000025/S084, FDA–2016–M–2974 MED–EL Corp .................................. MED–EL Cochlear Implant System ............................................................ 9/15/2016 P150021, FDA–2016–M–2971 .......... Abbott Diabetes Care, Inc ............... Freestyle Libre Pro Flash Glucose Monitoring System ............................. 9/23/2016 P080020/S020, FDA–2016–M–2975 Seikagaku Corp ............................... Gel-One® .................................................................................................... 9/27/2016 P160017, FDA–2016–M–1972 .......... Medtronic MiniMed, Inc .................... MiniMed 670G System ............................................................................... 9/28/2016 P150044, FDA–2016–M–2973 .......... Roche Molecular Systems, Inc ........ cobas® EGFR Mutation Test v2 ................................................................. 9/28/2016 P150030, FDA–2016–M–3430 .......... Smith & Nephew, Inc ....................... R3TM delta Ceramic Acetabular System .................................................... 10/17/2016 P160006, FDA–2016–M–3431 .......... Ventana Medical Systems, Inc ........ VENTANA PD–L1 (SP142) Assay ............................................................. 10/18/2016 P150013/S001, FDA–2016–M–3913 Dako North America, Inc ................. PD–L1 IHC 22C3 pharmDX ....................................................................... 10/24/2016 P120021, FDA–2016–M–3653 .......... St. Jude Medical, Inc ....................... AmplatzerTM PFO Occluder ....................................................................... 10/28/2016 P150043, FDA–2016–M–3914 .......... QView Medical, Inc .......................... QVCAD System .......................................................................................... 11/9/2016 P930016/S045, FDA–2016–M–3915 AMO Manufacturing USA, LLC ........ Star S4 IR Excimer Laser System and iDesign Advanced WaveScan 11/14/2016 Studio. P020050/S023, FDA–2016–M–4046 Alcon Laboratories, Inc .................... WaveLight® EX500 and ALLEGRETTO WAVE® EYE–Q Excimer Laser 11/21/2016 Systems. P140029, FDA–2016–M–4344 .......... Q-Med AB ........................................ Restylane® Refyne and Restylane® Defyne .............................................. 12/9/2016 P130007/S016, FDA–2016–M–4458 Animas Corporation ......................... OneTouch VibeTM Plus System ................................................................. 12/16/2016 P160018, FDA–2016–M–4459 .......... Foundation Medicine, Inc ................. FoundationFocusTM CDxBRACA Assay ....................................................... 12/19/2016 P120005/S041, FDA–2016–M–4483 Dexcom, Inc ..................................... Dexcom G5 Mobile Continuous Glucose Monitoring System .................... 12/20/2016 P040020/S049, FDA–2016–M–4657 Alcon Laboratories, Inc .................... Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens .............. 12/22/2016 P160019, FDA–2016–M–4530 .......... Roche Diagnostics ........................... Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg 12/23/2016 II. P100022/S020, FDA–2016–M–4653 Cook Medical Inc ............................. Zilver PTX Drug-Eluting Peripheral Stent .................................................. 12/28/2016 asabaliauskas on DSKBBXCHB2PROD with NOTICES H070005, FDA–2017–M–0180 .......... AGA Medical Corp ........................... AMPLATZERTM Post-Infarct Muscular VSD Occluder ............................... 1/10/2017 P160031, FDA–2017–M–0181 .......... FUJIFILM Medical Systems U.S.A., ASPIRE Cristalle Digital Breast Tomosynthesis Option ............................ 1/10/2017 Inc. P160008, FDA–2017–M–0229 .......... HeartSine Technologies LLC ........... HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public 1/12/2017 Access Automated External Defibrillators, Accessories and Saver EVO® Software Version 1.4.0. P160021, FDA–2017–M–0560 .......... W.L. Gore & Associates, Inc ........... Gore® Viabahn® VBX Balloon Expandable Endoprosthesis ..................... 1/27/2017 P130024/S009, FDA–2017–M–0831 Lutonix, Inc ....................................... Lutonix® 035 Drug Coated Balloon PTA Catheter ..................................... 2/7/2017 P140033, FDA–2017–M–0661 .......... St. Jude Medical, Inc ....................... MR Conditional Pacemaker System—Assurity MRITM and Endurity 1/31/2017 MRITM Pacemakers and Tendril MRITM 1200M LPA Lead. P160023, FDA–2017–M–0971 .......... Hologic, Inc ...................................... Aptima® HCV Quant Dx Assay .................................................................. 2/13/2017 VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1

44628 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2016 THROUGH JUNE 30, 2017—Continued Approval PMA No., Docket No. Applicant Trade name date P160003, FDA–2016–M–2652 .......... Biotronik, Inc .................................... PRO-Kinetic Energy Cobalt Chromium Coronary Stent System ............... 2/14/2017 P150039, FDA–2017–M–1121 .......... Tryton Medical, Inc .......................... TRYTON Side Branch Stent ...................................................................... 2/21/2017 P160014, FDA–2017–M–1122 .......... CeloNova BioSciences, Inc ............. COBRA PzFTM NanoCoated Coronary Stent System ............................... 2/21/2017 P100044/S023, FDA–2017–M–1228 Intersect ENT ................................... PROPEL® Contour Sinus Implant .............................................................. 2/23/2017 P140017/S005, FDA–2017–M–1227 Medtronic, Inc .................................. MelodyTM Transcatheter Pulmonary Valve, EnsembleTM Transcatheter 2/24/2017 Valve Delivery System and EnsembleTM II Transcatheter Valve Deliv- ery System. P160016, FDA–2017–M–1713 .......... Siemens Healthcare Diagnostics, VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) ...................................... 3/14/2017 Inc. P110033/S020, FDA–2017–M–1714 Allergan ............................................ Juvéderm VollureTM XC ............................................................................. 3/17/2017 P160025, FDA–2017–M–1845 .......... Biotronik, Inc .................................... Astron Pulsar and Pulsar-18 Stent Systems .............................................. 3/23/2017 P160009, FDA–2017–M–1950 .......... iCAD, Inc .......................................... PowerLook® Tomo Detection Software ..................................................... 3/24/2017 P160024, FDA–2017–M–2594 .......... Bard Peripheral Vascular, Inc .......... LifeStream Balloon Expandable Vascular Covered Stent ......................... 4/24/2017 P160043, FDA–2017–M–2767 .......... Medtronic, Inc .................................. Resolute Onyx Zotarolimus- Eluting Coronary Stent System .................... 4/28/2017 P160040, FDA–2017–M–2766 .......... Invivoscribe Technologies, Inc ......... LeukoStrat® CDx FLT3 Mutation Assay .................................................... 4/28/2017 P160046, FDA–2017–M–2768 .......... Ventana Medical Systems, Inc ........ VENTANA PD–L1 (SP263) Assay ............................................................. 5/1/2017 H150003, FDA–2017–M–3103 .......... Wilson-Cook Medical, Inc ................ FlourishTM Pediatric Esophageal Atresia Device ....................................... 5/12/2017 P160044, FDA–2017–M–3200 .......... Abbott Molecular, Inc ....................... Abbott RealTime CMV ................................................................................ 5/18/2017 P160041, FDA–2017–M–3430 .......... Roche Molecular Systems, Inc ........ cobas® CMV ............................................................................................... 6/1/2017 P140031/S028, FDA–2017–M–3579 Edwards Lifesciences LLC .............. Edwards SAPIEN 3TM Transcatheter Heart Valve and Accessories ......... 6/5/2017 P160035, FDA–2017–M–3580 .......... Berlin Heart, Inc ............................... EXCOR® Pediatric Ventricular Assist Device ............................................ 6/6/2017 P160047, FDA–2017–M–3778 .......... AEGEA Medical, Inc ........................ AEGEA Vapor SystemTM ........................................................................... 6/14/2017 H160002, FDA–2017–M–3839 .......... Pulsar Vascular, Inc ......................... PulseRider® Aneurysm Neck Reconstruction Device (‘‘PulseRider’’) ....... 6/19/2017 P160045, FDA–2017–M–3928 .......... Life Technologies Corp .................... OncomineTM Dx Target Test ...................................................................... 6/22/2017 P150046, FDA–2017–M–3982 .......... SciBase AB ...................................... Nevisense ................................................................................................... 6/28/2017 P150048, FDA–2017–M–3990 .......... Edwards Lifesciences, LLC ............. Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS 6/29/2017 RESILIA Aortic Valve. P160038, FDA–2017–M–3983 .......... Illumina, Inc ...................................... PraxisTM Extended RAS Panel .................................................................. 6/29/2017 II. Electronic Access sell, distributes, or imports cigars in • Federal eRulemaking Portal: Persons with access to the Internet small packages with respect to the https://www.regulations.gov. Follow the may obtain the documents at https:// warning statement requirements in instructions for submitting comments. www.fda.gov/MedicalDevices/ FDA’s regulations deeming other Comments submitted electronically, ProductsandMedicalProcedures/ products that meet the statutory including attachments, to https:// DeviceApprovalsandClearances/ definition of a tobacco product to be www.regulations.gov will be posted to PMAApprovals/default.htm. subject to Chapter IX of the Federal the docket unchanged. Because your Food, Drug, and Cosmetic Act (the comment will be made public, you are Dated: September 12, 2017. FD&C Act). The guidance describes solely responsible for ensuring that your Anna K. Abram, FDA’s compliance policy for cigars in comment does not include any Deputy Commissioner for Policy, Planning, packaging that is too small or otherwise confidential information that you or a Legislation, and Analysis. unable to accommodate a label with third party may not wish to be posted, [FR Doc. 2017–20391 Filed 9–22–17; 8:45 am] sufficient space to bear the required such as medical information, your or BILLING CODE 4164–01–P warning statements. The guidance anyone else’s Social Security number, or explains that FDA does not intend to confidential business information, such take enforcement action with respect to as a manufacturing process. Please note DEPARTMENT OF HEALTH AND cigars that do not comply with the size that if you include your name, contact HUMAN SERVICES and placement requirements in the information, or other information that regulation when the information and identifies you in the body of your Food and Drug Administration specifications required under the comments, that information will be [Docket No. FDA–2017–D–0121] regulation appear on the carton or other posted on https://www.regulations.gov. outer container or wrapper that could • If you want to submit a comment Compliance Policy for Required accommodate the required warning with confidential information that you Warning Statements on Small- statements, or on a tag otherwise firmly do not wish to be made available to the Packaged Cigars; Guidance for and permanently affixed to the cigar public, submit the comment as a Industry; Availability package. written/paper submission and in the manner detailed (see ‘‘Written/Paper AGENCY: Food and Drug Administration, DATES: The announcement of the Submissions’’ and ‘‘Instructions’’). HHS. guidance is published in the Federal ACTION: Notice of availability. Written/Paper Submissions Register on September 25, 2017. asabaliauskas on DSKBBXCHB2PROD with NOTICES Submit written/paper submissions as SUMMARY: The Food and Drug ADDRESSES: You may submit either follows: Administration (FDA) is announcing the electronic or written comments on • Mail/Hand delivery/Courier (for availability of a guidance for industry Agency guidances at any time as written/paper submissions): Dockets entitled ‘‘Compliance Policy for follows: Management Staff (HFA–305), Food and Required Warning Statements on Small- Electronic Submissions Drug Administration, 5630 Fishers Packaged Cigars.’’ The guidance is Lane, Rm. 1061, Rockville, MD 20852. intended to assist any person who Submit electronic comments in the • For written/paper comments manufactures, packages, sells, offers to following way: submitted to the Dockets Management VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1


Document Created: 2018-10-24 14:42:51
Document Modified: 2018-10-24 14:42:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactJoshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.
FR Citation82 FR 44626 
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