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

 
CONTENT

Federal Register, Volume 83 Issue 222 (Friday, November 16, 2018)

Federal Register Volume 83, Number 222 (Friday, November 16, 2018)

Notices

Pages 57730-57732

From the Federal Register Online via the Government Publishing Office www.gpo.gov

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.gpo.gov/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:

  1. 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.................................... Blazersupreg 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 CRsupreg Plus 12/21/2017

    Defibrillator, LIFEPAK

    EXPRESSsupreg Defibrillator

    and CHARGE-PAKsupreg Battery

    Charger.

    P140032, FDA-2017-M-6984...................... Medtronic, Inc....................................... Implantable System for 12/22/2017

    Remodulinsupreg.

    P160022, FDA-2017-M-7004...................... ZOLL Medical Corp.................................... X Seriessupreg, R 12/27/2017

    Seriessupreg, AED Prosupreg,

    and AED 3TM BLSsupreg

    Professional Defibrillators, Pro-

    Padz Radiotransparent Electrode,

    SurePowerTM Battery Pack,

    SurePower IITM Battery Pack, AED

    Prosupreg Non-Rechargeable

    Lithium Battery Pack, AED 3TM

    Battery Pack, SurePowerTM

    Charger, and SurePowerTM Single

    Bay Charger.

    P170025, FDA-2018-M-0411...................... Hologic, Inc......................................... Aptimasupreg 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 ProGlidesupreg 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............................ LIPOSORBERsupreg 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.......................... GOREsupreg 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............................ Restylanesupreg 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................................... enVistasupreg 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......................... AUGMENTsupreg 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......................................... Zephyrsupreg Endobronchial 6/29/2018

    Valve System.

    P160026, FDA-2018-M-2883...................... Physio-Control, Inc.................................. LIFEPAKsupreg 1000 7/2/2018

    Defibrillator, LIFEPAKsupreg

    1000 Defibrillator Lithium-Ion

    Rechargeable Battery,

    LIFEPAKsupreg 1000

    Defibrillator Non-Rechargeable

    Battery, LIFEPAKsupreg 20

    Defibrillator/Monitor

    (Refurbished), LIFEPAKsupreg

    20e Defibrillator/Monitor,

    LIFEPAKsupreg 15 Monitor/

    Defibrillator, LIFEPAKsupreg

    Lithium-ion Rechargeable Battery

    (for use with the

    LIFEPAKsupreg 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 Sentimagsupreg 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......................................... Hydrussupreg 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.................................... Visiansupreg TORIC ICL 9/13/2018

    (Implantable Collamersupreg

    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.

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

  2. 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