81_FR_6891 81 FR 6865 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

81 FR 6865 - 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 81, Issue 26 (February 9, 2016)

Page Range6865-6866
FR Document2016-02522

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 Division of Dockets Management.

Federal Register, Volume 81 Issue 26 (Tuesday, February 9, 2016) 
[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6865-6866]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-
2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-
2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-
2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-
2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-
2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951]


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 Division of Dockets Management.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376, 
FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519, 
FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014, 
FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018, 
FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434, 
FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951 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 http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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

[[Page 6866]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 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 sections 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 October 1, 2015, through December 31, 
2015. 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 October 1, 2015,
                                            Through December 31, 2015
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                    Applicant                   Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P150010, FDA-2015-M-3256...............  Fidia Farmaceutici,        HYMOVIS[supreg].............       8/28/2015
                                          S.p.A..
P100006, FDA-2015-M-3257...............  Biomimetic Therapeutics,   Augment[supreg] Bone Graft..        9/1/2015
                                          LLC.
P140005, FDA-2015-M-3258...............  OrthogenRx, Inc..........  GenVisc 850[supreg].........        9/2/2015
P140015, FDA-2015-M-3376...............  Tandem Diabetes Care,      t:slim G4 Insulin Pump With         9/8/2015
                                          Inc..                      Dexcom G4 Platinum CGM.
P140016, FDA-2015-M-3377...............  Cook Medical Inc.........  Zenith Alpha Thoracic              9/15/2015
                                                                     Endovascular Graft.
P070015/S128, FDA-2015-M-3516..........  Abbott Vascular..........  XIENCE V and XIENCE nano           9/23/2015
                                                                     Everolimus Eluting Coronary
                                                                     Stent System.
P110019/S075, FDA-2015-M-3516..........  Abbott Vascular..........  XIENCE PRIME and XIENCE            9/23/2015
                                                                     PRIME LL Everolimus Eluting
                                                                     Coronary Stent System,
                                                                     XIENCE Xpedition, XIENCE
                                                                     Xpedition SV and XIENCE
                                                                     Xpedition LL Everolimus
                                                                     Eluting Coronary Stent
                                                                     System, and XIENCE Alpine
                                                                     Everolimus Eluting Coronary
                                                                     Stent System.
P050047/S044, FDA-2015-M-3519..........  Allergan.................  Juv[eacute]derm Ultra XC           9/30/2015
                                                                     injectable gel.
P120010/S046, FDA-2015-M-4013..........  Medtronic, Inc...........  MiniMed 530G System with           10/2/2015
                                                                     Threshold Suspend featuring
                                                                     SmartGuardTM technology.
P150003, FDA-2015-M-4014...............  Boston Scientific          SYNERGYTM Everolimus-Eluting       10/2/2015
                                          Corporation.               Platinum Chromium Coronary
                                                                     Stent System.
P150013, FDA-2015-M-3520...............  Dako North America, Inc..  PD-L1 IHC 22C3 pharmDx......       10/2/2015
P100034/S013, FDA-2015-M-4015..........  Novocure, Ltd............  OptuneTM (Formerly the             10/5/2015
                                                                     NovoTTF-100A System).
P150025, FDA-2015-M-4016...............  Dako North America, Inc..  PD-L1 IHC 28-8 pharmDx......       10/9/2015
P130009/S034, FDA-2015-M-4017..........  Edwards Lifesciences, LLC  Edwards SAPIEN XTTM                10/9/2015
                                                                     Transcatheter Heart Valve,
                                                                     model 9300TFX, and
                                                                     Accessories.
P150014, FDA-2015-M-4069...............  Roche Molecular Systems,   cobas[supreg] HBV...........      10/14/2015
                                          Inc..
P150015, FDA-2015-M-4018...............  Roche Molecular Systems,   cobas[supreg] HCV...........      10/14/2015
                                          Inc..
P140019, FDA-2015-M-4343...............  Cerapedics, Inc..........  i-FACTORTM Peptide Enhanced        11/3/2015
                                                                     Bone Graft.
P120019/S007, FDA-2015-M-4344..........  Roche Molecular Systems,   cobas[supreg] EGFR Mutation       11/13/2015
                                          Inc..                      Test v2.
P130028, FDA-2015-M-4434...............  Algostim, LLC............  Algovita Spinal Cord              11/20/2015
                                                                     Stimulation System.
P150019, FDA-2015-M-4728...............  Medtronic MiniMed........  Paradigm Real-Time Revel           12/7/2015
                                                                     System.
P010030/S056, FDA-2015-M-3521..........  ZOLL Manufacturing         LifeVest Wearable                 12/17/2015
                                          Corporation.               Cardioverter Defibrillator
                                                                     Models 3000, 3100, and 4000.
P140030, FDA-2015-M-4947...............  Biotronik, Inc...........  Astron Peripheral Self-           12/17/2015
                                                                     Expanding Nitinol Stent
                                                                     System.
P980044/S027, FDA-2015-M-4951..........  Seikagaku Corporation....  VISCO-3TM...................      12/21/2015
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

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

    Dated: February 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02522 Filed 2-8-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6865 meeting registration is available at: DEPARTMENT OF HEALTH AND Written/Paper Submissions http://eclkc.ohs.acf.hhs.gov/hslc/hs/ HUMAN SERVICES Submit written/paper submissions as calendar/tc2016. follows: Food and Drug Administration • Mail/Hand delivery/Courier (for SUPPLEMENTARY INFORMATION: HHS announces OHS Tribal Consultations for [Docket Nos. FDA–2015–M–3256, FDA– written/paper submissions): Division of leaders of Tribal Governments operating 2015–M–3257, FDA–2015–M–3258, FDA– Dockets Management (HFA–305), Food Head Start and Early Head Start 2015–M–3376, FDA–2015–M–3377, FDA– and Drug Administration, 5630 Fishers programs. The agenda for the scheduled 2015–M–3516, FDA–2015–M–3516, FDA– Lane, Rm. 1061, Rockville, MD 20852. 2015–M–3519, FDA–2015–M–3520, FDA– • For written/paper comments OHS Tribal Consultations in 2015–M–3521, FDA–2015–M–4013, FDA– submitted to the Division of Dockets Albuquerque, New Mexico, Arlington, 2015–M–4014, FDA–2015–M–4015, FDA– Management, FDA will post your Virginia, and Spokane, Washington, will 2015–M–4016, FDA–2015–M–4017, FDA– comment, as well as any attachments, be organized around the statutory 2015–M–4018, FDA–2015–M–4069, FDA– except for information submitted, purposes of Head Start Tribal 2015–M–4343, FDA–2015–M–4344, FDA– 2015–M–4434, FDA–2015–M–4728, FDA– marked and identified, as confidential, Consultations related to meeting the if submitted as detailed in 2015–M–4947, and FDA–2015–M–4951] needs of American Indian and Alaska ‘‘Instructions.’’ Native children and families, taking into Medical Devices; Availability of Safety Instructions: All submissions received consideration funding allocations, and Effectiveness Summaries for must include the Docket Nos. FDA– distribution formulas, and other issues Premarket Approval Applications 2015–M–3256, FDA–2015–M–3257, affecting the delivery of Head Start FDA–2015–M–3258, FDA–2015–M– services in their geographic locations. In AGENCY: Food and Drug Administration, 3376, FDA–2015–M–3377, FDA–2015– addition, OHS will share actions taken HHS. M–3516, FDA–2015–M–3516, FDA– and in progress to address the issues ACTION: Notice. 2015–M–3519, FDA–2015–M–3520, and concerns raised in the 2015 OHS FDA–2015–M–3521, FDA–2015–M– SUMMARY: The Food and Drug 4013, FDA–2015–M–4014, FDA–2015– Tribal Consultations. Administration (FDA) is publishing a M–4015, FDA–2015–M–4016, FDA– The Consultation Sessions will be list of premarket approval applications 2015–M–4017, FDA–2015–M–4018, conducted with elected or appointed (PMAs) that have been approved. This FDA–2015–M–4069, FDA–2015–M– leaders of Tribal Governments and their list is intended to inform the public of 4343, FDA–2015–M–4344, FDA–2015– designated representatives [42 U.S.C. the availability of safety and M–4434, FDA–2015–M–4728, FDA– 9835, section 640(l)(4)(A)]. Designees effectiveness summaries of approved 2015–M–4947, and FDA–2015–M–4951 must have a letter from the Tribal PMAs through the Internet and the for ‘‘Medical Devices; Availability of Government authorizing them to Agency’s Division of Dockets Safety and Effectiveness Summaries for represent the tribe. Tribal Governments Management. Premarket Approval Applications.’’ must submit the designee letter at least ADDRESSES: You may submit comments Received comments will be placed in 3 days in advance of the Consultation as follows: the docket and, except for those Session to Angie Godfrey at submitted as ‘‘Confidential Angie.Godfrey@acf.hhs.gov. Other Electronic Submissions Submissions,’’ publicly viewable at representatives of tribal organizations Submit electronic comments in the http://www.regulations.gov or at the and Native nonprofit organizations are following way: Division of Dockets Management welcome to attend as observers. • Federal eRulemaking Portal: http:// between 9 a.m. and 4 p.m., Monday A detailed report of each Consultation www.regulations.gov. Follow the through Friday. instructions for submitting comments. • Confidential Submissions—To Session will be prepared and made Comments submitted electronically, submit a comment with confidential available within 45 days of the including attachments, to http:// information that you do not wish to be Consultation Sessions to all Tribal www.regulations.gov will be posted to made publicly available, submit your Governments receiving funds for Head the docket unchanged. Because your comments only as a written/paper Start and Early Head Start programs. comment will be made public, you are submission. You should submit two Tribes wishing to submit written solely responsible for ensuring that your copies total. One copy will include the testimony for the report should send comment does not include any information you claim to be confidential testimony to Angie Godfrey at confidential information that you or a with a heading or cover note that states Angie.Godfrey@acf.hhs.gov either prior third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS to each Consultation Session or within such as medical information, your or CONFIDENTIAL INFORMATION’’. The 30 days after each meeting. OHS will anyone else’s Social Security number, or Agency will review this copy, including summarize oral testimony and confidential business information, such the claimed confidential information, in comments from the Consultation as a manufacturing process. Please note its consideration of comments. The Session in each report without that if you include your name, contact second copy, which will have the attribution, along with topics of concern information, or other information that claimed confidential information and recommendations. identifies you in the body of your redacted/blacked out, will be available Dated: February 2, 2016. comments, that information will be for public viewing and posted on mstockstill on DSK4VPTVN1PROD with NOTICES posted on http://www.regulations.gov. http://www.regulations.gov. Submit Blanca E. Enriquez, • If you want to submit a comment both copies to the Division of Dockets Director, Office of Head Start. with confidential information that you Management. If you do not wish your [FR Doc. 2016–02580 Filed 2–8–16; 8:45 am] do not wish to be made available to the name and contact information to be BILLING CODE 4184–01–P public, submit the comment as a made publicly available, you can written/paper submission and in the provide this information on the cover manner detailed (see ‘‘Written/Paper sheet and not in the body of your Submissions’’ and ‘‘Instructions’’). comments and you must identify this VerDate Sep<11>2014 17:54 Feb 08, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1

6866 Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices information as ‘‘confidential.’’ Any FOR FURTHER INFORMATION CONTACT: Internet. Section 10.33(b) provides that information marked as ‘‘confidential’’ Joshua Nipper, Center for Devices and FDA may, for good cause, extend this will not be disclosed except in Radiological Health, Food and Drug 30-day period. Reconsideration of a accordance with 21 CFR 10.20 and other Administration, 10903 New Hampshire denial or withdrawal of approval of a applicable disclosure law. For more Ave., Bldg. 66, Rm. 1650, Silver Spring, PMA may be sought only by the information about FDA’s posting of MD 20993–0002, 301–796–6524. applicant; in these cases, the 30-day comments to public dockets, see 80 FR SUPPLEMENTARY INFORMATION: period will begin when the applicant is 56469, September 18, 2015, or access notified by FDA in writing of its I. Background decision. the information at: http://www.fda.gov/ regulatoryinformation/dockets/ In accordance with sections 515(d)(4) The regulations provide that FDA default.htm. and (e)(2) of the Federal Food, Drug, and publish a quarterly list of available Cosmetic Act (the FD&C Act) (21 U.S.C. safety and effectiveness summaries of Docket: For access to the docket to 360e(d)(4) and (e)(2)), notification of an PMA approvals and denials that were read background documents or the order approving, denying, or announced during that quarter. The electronic and written/paper comments withdrawing approval of a PMA will following is a list of approved PMAs for received, go to http:// continue to include a notice of which summaries of safety and www.regulations.gov and insert the opportunity to request review of the effectiveness were placed on the docket number, found in brackets in the order under section 515(g) of the FD&C Internet from October 1, 2015, through heading of this document, into the Act. The 30-day period for requesting December 31, 2015. There were no ‘‘Search’’ box and follow the prompts reconsideration of an FDA action under denial actions during this period. The and/or go to the Division of Dockets § 10.33(b) (21 CFR 10.33(b)) for notices list provides the manufacturer’s name, Management, 5630 Fishers Lane, Rm. announcing approval of a PMA begins the product’s generic name or the trade 1061, Rockville, MD 20852. on the day the notice is placed on the name, and the approval date. TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 2015, THROUGH DECEMBER 31, 2015 PMA No., Docket No. Applicant Trade name Approval date P150010, FDA–2015–M–3256 ........... Fidia Farmaceutici, S.p.A. ............ HYMOVIS® .............................................................. 8/28/2015 P100006, FDA–2015–M–3257 ........... Biomimetic Therapeutics, LLC ..... Augment® Bone Graft .............................................. 9/1/2015 P140005, FDA–2015–M–3258 ........... OrthogenRx, Inc. .......................... GenVisc 850® .......................................................... 9/2/2015 P140015, FDA–2015–M–3376 ........... Tandem Diabetes Care, Inc. ........ t:slim G4 Insulin Pump With Dexcom G4 Platinum 9/8/2015 CGM. P140016, FDA–2015–M–3377 ........... Cook Medical Inc. ......................... Zenith Alpha Thoracic Endovascular Graft .............. 9/15/2015 P070015/S128, FDA–2015–M–3516 Abbott Vascular ............................ XIENCE V and XIENCE nano Everolimus Eluting 9/23/2015 Coronary Stent System. P110019/S075, FDA–2015–M–3516 Abbott Vascular ............................ XIENCE PRIME and XIENCE PRIME LL 9/23/2015 Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coro- nary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System. P050047/S044, FDA–2015–M–3519 Allergan ........................................ Juvéderm Ultra XC injectable gel ............................ 9/30/2015 P120010/S046, FDA–2015–M–4013 Medtronic, Inc. .............................. MiniMed 530G System with Threshold Suspend 10/2/2015 featuring SmartGuardTM technology. P150003, FDA–2015–M–4014 ........... Boston Scientific Corporation ....... SYNERGYTM Everolimus-Eluting Platinum Chro- 10/2/2015 mium Coronary Stent System. P150013, FDA–2015–M–3520 ........... Dako North America, Inc. ............. PD–L1 IHC 22C3 pharmDx ..................................... 10/2/2015 P100034/S013, FDA–2015–M–4015 Novocure, Ltd. .............................. OptuneTM (Formerly the NovoTTF–100A System) 10/5/2015 P150025, FDA–2015–M–4016 ........... Dako North America, Inc. ............. PD–L1 IHC 28–8 pharmDx ...................................... 10/9/2015 P130009/S034, FDA–2015–M–4017 Edwards Lifesciences, LLC .......... Edwards SAPIEN XTTM Transcatheter Heart 10/9/2015 Valve, model 9300TFX, and Accessories. P150014, FDA–2015–M–4069 ........... Roche Molecular Systems, Inc. ... cobas® HBV ............................................................. 10/14/2015 P150015, FDA–2015–M–4018 ........... Roche Molecular Systems, Inc. ... cobas® HCV ............................................................ 10/14/2015 P140019, FDA–2015–M–4343 ........... Cerapedics, Inc. ........................... i-FACTORTM Peptide Enhanced Bone Graft ........... 11/3/2015 P120019/S007, FDA–2015–M–4344 Roche Molecular Systems, Inc. ... cobas® EGFR Mutation Test v2 .............................. 11/13/2015 P130028, FDA–2015–M–4434 ........... Algostim, LLC ............................... Algovita Spinal Cord Stimulation System ................ 11/20/2015 P150019, FDA–2015–M–4728 ........... Medtronic MiniMed ....................... Paradigm Real-Time Revel System ........................ 12/7/2015 P010030/S056, FDA–2015–M–3521 ZOLL Manufacturing Corporation LifeVest Wearable Cardioverter Defibrillator Models 12/17/2015 3000, 3100, and 4000. P140030, FDA–2015–M–4947 ........... Biotronik, Inc. ................................ Astron Peripheral Self-Expanding Nitinol Stent Sys- 12/17/2015 tem. P980044/S027, FDA–2015–M–4951 Seikagaku Corporation ................. VISCO–3TM .............................................................. 12/21/2015 mstockstill on DSK4VPTVN1PROD with NOTICES II. Electronic Access ApprovalsandClearances/PMA Dated: February 2, 2016. Approvals/default.htm. Leslie Kux, Persons with access to the Internet Associate Commissioner for Policy. may obtain the documents at http:// [FR Doc. 2016–02522 Filed 2–8–16; 8:45 am] www.fda.gov/MedicalDevices/Products andMedicalProcedures/Device BILLING CODE 4164–01–P VerDate Sep<11>2014 17:54 Feb 08, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 E:\FR\FM\09FEN1.SGM 09FEN1


Document Created: 2018-02-02 14:30:00
Document Modified: 2018-02-02 14:30:00
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 Citation81 FR 6865 
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