83 FR 57730 - 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 83, Issue 222 (November 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 222 (November 16, 2018)
| Page Range | 57730-57732 | |
| FR Document | 2018-25071 |
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)] [Notices] [Pages 57730-57732] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25071] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA- 2017-M-6984, FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA- 2018-M-0620, FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA- 2018-M-0792, FDA-2018-M-1371, FDA-2018-M-1215, FDA-2018-M-1237, FDA- 2018-M-1372, FDA-2018-M-1446, FDA-2018-M-1447, FDA-2018-M-1580, FDA- 2018-M-1581, FDA-2018-M-1634, FDA-2018-M-1727, FDA-2018-M-1791, FDA- 2018-M-1753, FDA-2018-M-1970, FDA-2018-M-2118, FDA-2018-M-2119, FDA- 2018-M-2237, FDA-2018-M-2269, FDA-2018-M-2335, FDA-2018-M-2460, FDA- 2018-M-2461, FDA-2018-M-2462, FDA-2018-M-2463, FDA-2018-M-2571, FDA- 2018-M-2883, FDA-2018-M-2884, FDA-2018-M-2885, FDA-2018-M-2886, FDA- 2018-M-2887, FDA-2018-M-2983, FDA-2018-M-3131, FDA-2018-M-3153, FDA- 2018-M-3212, FDA-2018-M-3503, FDA-2018-M-3505, and FDA-2018-M-3548] 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) and humanitarian device exemption applications (HDEs), 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-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA-2017-M-6984, FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA-2018-M-0620, FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA-2018-M-0792, FDA-2018-M-1371, FDA-2018-M-1215, FDA-2018-M-1237, FDA-2018-M-1372, FDA-2018-M-1446, FDA-2018-M-1447, FDA-2018-M-1580, FDA-2018-M-1581, FDA-2018-M-1634, FDA-2018-M-1727, FDA-2018-M-1791, FDA-2018-M-1753, FDA-2018-M-1970, FDA-2018-M-2118, FDA-2018-M-2119, FDA-2018-M-2237, FDA-2018-M-2269, FDA-2018-M-2335, FDA-2018-M-2460, FDA-2018-M-2461, FDA-2018-M-2462, FDA-2018-M-2463, FDA-2018-M-2571, FDA-2018-M-2883, FDA-2018-M-2884, FDA-2018-M-2885, FDA-2018-M-2886, FDA-2018-M-2887, FDA-2018-M-2983, FDA-2018-M-3131, FDA-2018-M-3153, FDA-2018-M-3212, FDA-2018-M-3503, FDA-2018-M-3505, and FDA-2018-M-3548 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 . [[Page 57731]] 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 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 (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 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 January 1, 2018, through September 18, 2018. 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 and Safety and Probable Benefit Summaries for Approved HDEs Made Available From January 1, 2018, Through September 18, 2018 -------------------------------------------------------------------------------------------------------------------------------------------------------- PMA No., Docket No. Applicant Trade name Approval date -------------------------------------------------------------------------------------------------------------------------------------------------------- P150005/S014, FDA-2017-M-6970................. Boston Scientific.................................... Blazer[supreg] Open-Irrigated 12/21/2017 Ablation Catheter and IntellaNavTM Open-Irrigated Ablation Catheter. P100030/S008, FDA-2017-M-6971................. Mallinckrodt Pharma IP Trading DAC................... PREVELEAK Surgical Sealant....... 12/21/2017 P160012, FDA-2017-M-6983...................... Physio-Control, Inc.................................. LIFEPAK CR[supreg] Plus 12/21/2017 Defibrillator, LIFEPAK EXPRESS[supreg] Defibrillator and CHARGE-PAK[supreg] Battery Charger. P140032, FDA-2017-M-6984...................... Medtronic, Inc....................................... Implantable System for 12/22/2017 Remodulin[supreg]. P160022, FDA-2017-M-7004...................... ZOLL Medical Corp.................................... X Series[supreg], R 12/27/2017 Series[supreg], AED Pro[supreg], and AED 3TM BLS[supreg] Professional Defibrillators, Pro- Padz Radiotransparent Electrode, SurePowerTM Battery Pack, SurePower IITM Battery Pack, AED Pro[supreg] Non-Rechargeable Lithium Battery Pack, AED 3TM Battery Pack, SurePowerTM Charger, and SurePowerTM Single Bay Charger. P170025, FDA-2018-M-0411...................... Hologic, Inc......................................... Aptima[supreg] HBV Quant Assay... 1/23/2018 P160032, FDA-2018-M-0528...................... Defibtech, LLC....................................... Lifeline/ReviveR DDU-100, 2/1/2018 Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- 2200, Lifeline/ReviveR ECG DDU- 2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators. P140003/S018, FDA-2018-M-0620................. Abiomed, Inc......................................... Impella Ventricular Support 2/7/2018 Systems. P160037, FDA-2018-M-0736...................... Becton, Dickinson and Co............................. BD Onclarity HPV Assay........... 2/12/2018 P150001/S021, FDA-2018-M-0737................. Medtronic MiniMed, Inc............................... MiniMed 630G System.............. 2/13/2018 P160017/S017, FDA-2018-M-0738................. Medtronic MiniMed, Inc............................... MiniMed 670G System.............. 2/13/2018 P960043/S097, FDA-2018-M-0792................. Abbott Vascular...................................... Perclose ProGlide[supreg] Suture- 2/16/2018 Mediated Closure System. P160007, FDA-2018-M-1371...................... Medtronic MiniMed, Inc............................... Guardian Connect System.......... 3/8/2018 H170002, FDA-2018-M-1215...................... Kaneka Pharma America LLC............................ LIPOSORBER[supreg] LA-15 System.. 3/20/2018 P160013, FDA-2018-M-1237...................... TransMedics, Inc..................................... Organ Care System (OCSTM) Lung 3/22/2018 System. P050006/S060, FDA-2018-M-1372................. W.L. Gore & Associates, Inc.......................... GORE[supreg] CARDIOFORM Septal 3/30/2018 Occluder. P160018/S001, FDA-2018-M-1446................. Foundation Medicine, Inc............................. FoundationFocusTM CDx BRCA LOH... 4/6/2018 P150009, FDA-2018-M-1447...................... Angel Medical Systems, Inc........................... AngelMed Guardian System......... 4/9/2018 P160052, FDA-2018-M-1581...................... Parsagen Diagnostics, Inc............................ PartoSure Test................... 4/11/2018 P950039/S036, FDA-2018-M-1580................. Hologic, Inc......................................... ThinPrep Integrated Imager....... 4/18/2018 P140010/S037, FDA-2018-M-1634................. Medtronic Vascular, Inc.............................. IN.PACTTM AdmiralTM Paclitaxel- 4/19/2018 Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. P960009/S219, FDA-2018-M-1727................. Medtronic, Inc....................................... Medtronic DBS System for Epilepsy 4/27/2018 P170035, FDA-2018-M-1791...................... Bausch + Lomb, Inc................................... Bausch + Lomb ULTRA (samfilcon A) 4/30/2018 Contact Lenses. P170016, FDA-2018-M-1753...................... Teva Pharmaceuticals USA, Inc........................ SYNOJOYNTTM...................... 5/8/2018 P040024/S099, FDA-2018-M-1970................. Galderma Laboratories, LP............................ Restylane[supreg] Lyft with 5/18/2018 Lidocaine. P170013, FDA-2018-M-2118...................... MicroVention, Inc.................................... Low-Profile Visualized 5/30/2018 Intraluminal Support (LVIS) and LVIS Jr. P170039, FDA-2018-M-2119...................... Clinical Research Consultants, Inc................... CustomFlexTM Artificial Iris..... 5/30/2018 P910056/S027, FDA-2018-M-2237................. Bausch + Lomb, Inc................................... enVista[supreg] One-Piece 6/8/2018 Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T). P150013/S009, FDA-2018-M-2269................. Dako North America, Inc.............................. PD-L1 IHC 22C3 pharmDx........... 6/12/2018 P100006/S005, FDA-2018-M-2335................. BioMimetic Therapeutics, LLC......................... AUGMENT[supreg] Injectable....... 6/12/2018 P170043, FDA-2018-M-2460...................... Glaukos Corp......................................... iStent inject Trabecular Micro- 6/21/2018 Bypass System (Model G2-M-IS). [[Page 57732]] P160017/S031, FDA-2018-M-2461................. Medtronic MiniMed, Inc............................... MiniMed 670G System.............. 6/21/2018 P160048, FDA-2018-M-2463...................... Senseonics, Inc...................................... Eversense Continuous Glucose 6/21/2018 Monitoring System. P180008, FDA-2018-M-2462...................... Tandem Diabetes Care, Inc............................ t:slim X2 Insulin Pump with Basal- 6/21/2018 IQ Technology. P180002, FDA-2018-M-2571...................... Pulmonx Corp......................................... Zephyr[supreg] Endobronchial 6/29/2018 Valve System. P160026, FDA-2018-M-2883...................... Physio-Control, Inc.................................. LIFEPAK[supreg] 1000 7/2/2018 Defibrillator, LIFEPAK[supreg] 1000 Defibrillator Lithium-Ion Rechargeable Battery, LIFEPAK[supreg] 1000 Defibrillator Non-Rechargeable Battery, LIFEPAK[supreg] 20 Defibrillator/Monitor (Refurbished), LIFEPAK[supreg] 20e Defibrillator/Monitor, LIFEPAK[supreg] 15 Monitor/ Defibrillator, LIFEPAK[supreg] Lithium-ion Rechargeable Battery (for use with the LIFEPAK[supreg] 15 Monitor/ Defibrillator). P170024, FDA-2018-M-2884...................... Stryker Neurovascular................................ Surpass Streamline Flow Diverter. 7/13/2018 P170041, FDA-2018-M-2885...................... Abbott Molecular, Inc................................ Abbott RealTime IDH1............. 7/20/2018 P160030/S017, FDA-2018-M-2886................. Abbott Diabetes Care Inc............................. FreeStyle Libre 14 Day Flash 7/23/2018 Glucose Monitoring System. P160053, FDA-2018-M-2887...................... Endomagnetics Ltd.................................... MagtraceTM and Sentimag[supreg] 7/24/2018 Magnetic Localization System. P170042, FDA-2018-M-2983...................... C.R. Bard, Inc....................................... COVERATM Vascular Covered Stent.. 7/30/2018 P150048/S012, FDA-2018-M-3131................. Edwards Lifesciences LLC............................. Edwards Pericardial Mitral 8/9/2018 Bioprosthesis, Model 11000M. P170034, FDA-2018-M-3153...................... Ivantis, Inc......................................... Hydrus[supreg] Microstent........ 8/10/2018 P150013/S011, FDA-2018-M-3212................. Dako North America, Inc.............................. PD-L1 IHC 22C3 pharmDx........... 8/16/2018 P030016/S001, FDA-2018-M-3503................. STAAR Surgical Co.................................... Visian[supreg] TORIC ICL 9/13/2018 (Implantable Collamer[supreg] Lens). H170004, FDA-2018-M-3505...................... BIOTRONIK, Inc....................................... PK Papyrus Covered Coronary Stent 9/14/2018 System. P180011, FDA-2018-M-3548...................... Boston Scientific Corp............................... ELUVIATM Drug-Eluting Vascular 9/18/2018 Stent System. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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: November 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25071 Filed 11-15-18; 8:45 am] BILLING CODE 4164-01-P
![57730 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
Estimated Total Annual Burden SUMMARY: The Food and Drug 0738, FDA–2018–M–0792, FDA–2018–
Hours: 155,529. Administration (FDA) is publishing a M–1371, FDA–2018–M–1215, FDA–
Additional Information: Copies of the list of premarket approval applications 2018–M–1237, FDA–2018–M–1372,
proposed collection may be obtained by (PMAs) and humanitarian device FDA–2018–M–1446, FDA–2018–M–
writing to the Administration for exemption applications (HDEs), that 1447, FDA–2018–M–1580, FDA–2018–
Children and Families, Office of have been approved. This list is M–1581, FDA–2018–M–1634, FDA–
Planning, Research and Evaluation, 330 intended to inform the public of the 2018–M–1727, FDA–2018–M–1791,
C Street SW, Washington, DC 20201. availability of safety and effectiveness FDA–2018–M–1753, FDA–2018–M–
Attention Reports Clearance Officer. All summaries of approved PMAs through 1970, FDA–2018–M–2118, FDA–2018–
requests should be identified by the title the internet and the Agency’s Dockets M–2119, FDA–2018–M–2237, FDA–
of the information collection. Email Management Staff. 2018–M–2269, FDA–2018–M–2335,
address: infocollection@acf.hhs.gov. ADDRESSES: You may submit comments FDA–2018–M–2460, FDA–2018–M–
OMB Comment: OMB is required to as follows: 2461, FDA–2018–M–2462, FDA–2018–
make a decision concerning the M–2463, FDA–2018–M–2571, FDA–
collection of information between 30 Electronic Submissions
2018–M–2883, FDA–2018–M–2884,
and 60 days after publication of this Submit electronic comments in the FDA–2018–M–2885, FDA–2018–M–
document in the Federal Register. following way: 2886, FDA–2018–M–2887, FDA–2018–
Therefore, a comment is best assured of • Federal eRulemaking Portal: M–2983, FDA–2018–M–3131, FDA–
having its full effect if OMB receives it https://www.regulations.gov. Follow the 2018–M–3153, FDA–2018–M–3212,
within 30 days of publication. Written instructions for submitting comments. FDA–2018–M–3503, FDA–2018–M–
comments and recommendations for the Comments submitted electronically, 3505, and FDA–2018–M–3548 for
proposed information collection should including attachments, to https:// ‘‘Medical Devices; Availability of Safety
be sent directly to the following: Office www.regulations.gov will be posted to and Effectiveness Summaries for
of Management and Budget Paperwork the docket unchanged. Because your Premarket Approval Applications.’’
Reduction Project Email: OIRA_ comment will be made public, you are Received comments will be placed in
SUBMISSION@OMB.EOP.GOV. Attn: solely responsible for ensuring that your the docket and, except for those
Desk Officer for the Administration for comment does not include any submitted as ‘‘Confidential
Children and Families. confidential information that you or a Submissions,’’ publicly viewable at
third party may not wish to be posted, https://www.regulations.gov or at the
Robert Sargis, such as medical information, your or
Reports Clearance Officer.
Dockets Management Staff between 9
anyone else’s Social Security number, or a.m. and 4 p.m., Monday through
[FR Doc. 2018–25053 Filed 11–15–18; 8:45 am] confidential business information, such Friday.
BILLING CODE 4184–01–P as a manufacturing process. Please note
• Confidential Submissions—To
that if you include your name, contact
submit a comment with confidential
information, or other information that
DEPARTMENT OF HEALTH AND information that you do not wish to be
identifies you in the body of your
HUMAN SERVICES made publicly available, submit your
comments, that information will be
comments only as a written/paper
posted on https://www.regulations.gov.
Food and Drug Administration • If you want to submit a comment submission. You should submit two
with confidential information that you copies total. One copy will include the
[Docket Nos. FDA–2017–M–6970, FDA–
2017–M–6971, FDA–2017–M–6983, FDA– do not wish to be made available to the information you claim to be confidential
2017–M–6984, FDA–2017–M–7004, FDA– public, submit the comment as a with a heading or cover note that states
2018–M–0411, FDA–2018–M–0528, FDA– written/paper submission and in the ‘‘THIS DOCUMENT CONTAINS
2018–M–0620, FDA–2018–M–0736, FDA–
manner detailed (see ‘‘Written/Paper CONFIDENTIAL INFORMATION.’’ The
2018–M–0737, FDA–2018–M–00–0738, FDA–
Submissions’’ and ‘‘Instructions’’). Agency will review this copy, including
2018–M–0792, FDA–2018–M–1371, FDA– the claimed confidential information, in
2018–M–1215, FDA–2018–M–1237, FDA– Written/Paper Submissions its consideration of comments. The
2018–M–1372, FDA–2018–M–1446, FDA–
Submit written/paper submissions as second copy, which will have the
2018–M–1447, FDA–2018–M–1580, FDA–
2018–M–1581, FDA–2018–M–1634, FDA– follows: claimed confidential information
2018–M–1727, FDA–2018–M–1791, FDA– • Mail/Hand Delivery/Courier (for redacted/blacked out, will be available
2018–M–1753, FDA–2018–M–1970, FDA– written/paper submissions): Dockets for public viewing and posted on
2018–M–2118, FDA–2018–M–2119, FDA– Management Staff (HFA–305), Food and https://www.regulations.gov. Submit
2018–M–2237, FDA–2018–M–2269, FDA– Drug Administration, 5630 Fishers both copies to the Dockets Management
2018–M–2335, FDA–2018–M–2460, FDA– Lane, Rm. 1061, Rockville, MD 20852. Staff. If you do not wish your name and
2018–M–2461, FDA–2018–M–2462, FDA– • For written/paper comments contact information to be made publicly
2018–M–2463, FDA–2018–M–2571, FDA– available, you can provide this
2018–M–2883, FDA–2018–M–2884, FDA–
submitted to the Dockets Management
2018–M–2885, FDA–2018–M–2886, FDA– Staff, FDA will post your comment, as information on the cover sheet and not
2018–M–2887, FDA–2018–M–2983, FDA– well as any attachments, except for in the body of your comments and you
2018–M–3131, FDA–2018–M–3153, FDA– information submitted, marked and must identify this information as
2018–M–3212, FDA–2018–M–3503, FDA– identified, as confidential, if submitted ‘‘confidential.’’ Any information marked
2018–M–3505, and FDA–2018–M–3548] as detailed in ‘‘Instructions.’’ as ‘‘confidential’’ will not be disclosed
Instructions: All submissions received except in accordance with 21 CFR 10.20
amozie on DSK3GDR082PROD with NOTICES
Medical Devices; Availability of Safety must include the Docket Nos. FDA– and other applicable disclosure law. For
and Effectiveness Summaries for 2017–M–6970, FDA–2017–M–6971, more information about FDA’s posting
Premarket Approval Applications FDA–2017–M–6983, FDA–2017–M– of comments to public dockets, see 80
AGENCY: Food and Drug Administration, 6984, FDA–2017–M–7004, FDA–2018– FR 56469, September 18, 2015, or access
HHS. M–0411, FDA–2018–M–0528, FDA– the information at: https://www.gpo.gov/
2018–M–0620, FDA–2018–M–0736, fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice.
FDA–2018–M–0737, FDA–2018–M–00– 23389.pdf .
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TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM JANUARY 1, 2018, THROUGH SEPTEMBER 18, 2018—
Continued
PMA No., Docket No. Applicant Trade name Approval date
P160017/S031, FDA–2018–M– Medtronic MiniMed, Inc ....................... MiniMed 670G System ................................................................................ 6/21/2018
2461.
P160048, FDA–2018–M–2463 .. Senseonics, Inc ................................... Eversense Continuous Glucose Monitoring System ................................... 6/21/2018
P180008, FDA–2018–M–2462 .. Tandem Diabetes Care, Inc ................ t:slim X2 Insulin Pump with Basal-IQ Technology ...................................... 6/21/2018
P180002, FDA–2018–M–2571 .. Pulmonx Corp ..................................... Zephyr® Endobronchial Valve System ........................................................ 6/29/2018
P160026, FDA–2018–M–2883 .. Physio-Control, Inc .............................. LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-Ion 7/2/2018
Rechargeable Battery, LIFEPAK® 1000 Defibrillator Non-Rechargeable
Battery, LIFEPAK® 20 Defibrillator/Monitor (Refurbished), LIFEPAK®
20e Defibrillator/Monitor, LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK®
Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Mon-
itor/Defibrillator).
P170024, FDA–2018–M–2884 .. Stryker Neurovascular ........................ Surpass Streamline Flow Diverter ............................................................... 7/13/2018
P170041, FDA–2018–M–2885 .. Abbott Molecular, Inc .......................... Abbott RealTime IDH1 ................................................................................ 7/20/2018
P160030/S017, FDA–2018–M– Abbott Diabetes Care Inc ................... FreeStyle Libre 14 Day Flash Glucose Monitoring System ........................ 7/23/2018
2886.
P160053, FDA–2018–M–2887 .. Endomagnetics Ltd ............................. MagtraceTM and Sentimag® Magnetic Localization System ....................... 7/24/2018
P170042, FDA–2018–M–2983 .. C.R. Bard, Inc ..................................... COVERATM Vascular Covered Stent .......................................................... 7/30/2018
P150048/S012, FDA–2018–M– Edwards Lifesciences LLC ................. Edwards Pericardial Mitral Bioprosthesis, Model 11000M .......................... 8/9/2018
3131.
P170034, FDA–2018–M–3153 .. Ivantis, Inc ........................................... Hydrus® Microstent ..................................................................................... 8/10/2018
P150013/S011, FDA–2018–M– Dako North America, Inc .................... PD–L1 IHC 22C3 pharmDx ......................................................................... 8/16/2018
3212.
P030016/S001, FDA–2018–M– STAAR Surgical Co ............................ Visian® TORIC ICL (Implantable Collamer® Lens) ..................................... 9/13/2018
3503.
H170004, FDA–2018–M–3505 .. BIOTRONIK, Inc ................................. PK Papyrus Covered Coronary Stent System ............................................ 9/14/2018
P180011, FDA–2018–M–3548 .. Boston Scientific Corp ........................ ELUVIATM Drug-Eluting Vascular Stent System ......................................... 9/18/2018
II. Electronic Access International Council for Harmonisation for the second public meeting, and by
Persons with access to the internet (ICH) E2B(R3) Standards.’’ The purpose March 20, 2020, for the third public
may obtain the documents at https:// of these public meetings is to provide meeting. See the SUPPLEMENTARY
www.fda.gov/MedicalDevices/ the pharmaceutical industry and other INFORMATION section for registration
ProductsandMedicalProcedures/ interested parties with information on dates and information.
DeviceApprovalsandClearances/ the plans, progress, and technical ADDRESSES: Each public meeting will be
PMAApprovals/default.htm. specifications to upgrade electronic held at the FDA White Oak Campus,
submission standards for drug, 10903 New Hampshire Ave., Bldg. 31
Dated: November 13, 2018. biological, and drug/biologic-led Conference Center, the Great Room (Rm.
Leslie Kux, combination products for the premarket 1503, Section A), Silver Spring, MD
Associate Commissioner for Policy. and postmarket safety surveillance 20993–0002. Entrance for the public
[FR Doc. 2018–25071 Filed 11–15–18; 8:45 am] programs managed by the Center for meeting participants (non-FDA
BILLING CODE 4164–01–P Drug Evaluation and Research (CDER) employees) is through Building 1, where
and the Center for Biologics Evaluation routine security check procedures will
and Research (CBER). These meetings be performed. For parking and security
DEPARTMENT OF HEALTH AND will focus on enhancements to information, please refer to https://
HUMAN SERVICES electronic submission of Individual www.fda.gov/AboutFDA/
Case Safety Reports (ICSRs) in FAERS WorkingatFDA/BuildingsandFacilities/
Food and Drug Administration using ICH E2B(R3) standards. WhiteOakCampusInformation/
[Docket No. FDA–2018–N–4002] FDA is seeking input from default.htm.
stakeholders as it fulfills its You may submit comments as
Electronic Submission of Adverse commitment to implement ICH E2B(R3) follows. Please note that late, untimely
Event Reports to the Food and Drug standards by holding three public filed comments will not be considered.
Administration Adverse Event meetings. FDA will use the information For timely consideration, we request
Reporting System Using International provided by the public to inform the that electronic comments be submitted
Council for Harmonisation E2B(R3) enhancements to FAERS required for before or within 30 days after each
Standards; Public Meetings; Request the implementation of ICH E2B(R3) public meeting (i.e., comments
for Comments standards and relevant regional submitted by or before February 25,
variations. 2019, for the first public meeting;
AGENCY: Food and Drug Administration,
HHS. DATES: The first public meeting will be August 16, 2019, for the second public
ACTION: Notice of public meetings; held on January 25, 2019, from 9 a.m. meeting; and March 20, 2020, for the
request for comments. to 4 p.m. The second public meeting third public meeting. The https://
amozie on DSK3GDR082PROD with NOTICES
will be held on July 17, 2019, from 9 www.regulations.gov electronic filing
SUMMARY: The Food and Drug a.m. to 4 p.m. The third public meeting system will accept comments until
Administration (FDA, the Agency, or will be held on February 19, 2020 from 11:59 p.m. Eastern Time at the end of
we) is announcing three public meetings 9 a.m. to 4 p.m. Submit either electronic February 25, 2019; August 16, 2019; and
entitled ‘‘Electronic Submission of or written comments on these public March 20, 2020, after the first, second,
Adverse Event Reports to FDA Adverse meetings by February 25, 2019, for the and the third meeting, respectively.
Event Reporting System (FAERS) Using first public meeting; by August 16, 2019, Comments received by mail/hand
VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1](https://thefederalregister.org/doc/83_FR_57952/page/3.svg)
Document Created: 2018-11-16 07:22:51
Document Modified: 2018-11-16 07:22:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 83 FR 57730 |
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