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Home » 2018 Issues » 83 FR (11/16/2018) » 2018-25071. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

  2018-25071. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications  

  • Start Preamble

    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 .Start Printed 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.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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 § 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.ApplicantTrade nameApproval date
    P150005/S014, FDA-2017-M-6970Boston ScientificBlazer® Open-Irrigated Ablation Catheter and IntellaNavTM Open-Irrigated Ablation Catheter12/21/2017
    P100030/S008, FDA-2017-M-6971Mallinckrodt Pharma IP Trading DACPREVELEAK Surgical Sealant12/21/2017
    P160012, FDA-2017-M-6983Physio-Control, IncLIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator and CHARGE-PAK® Battery Charger12/21/2017
    P140032, FDA-2017-M-6984Medtronic, IncImplantable System for Remodulin®12/22/2017
    P160022, FDA-2017-M-7004ZOLL Medical CorpX Series®, R Series®, AED Pro®, and AED 3TM BLS® Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePowerTM Battery Pack, SurePower IITM Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3TM Battery Pack, SurePowerTM Charger, and SurePowerTM Single Bay Charger12/27/2017
    P170025, FDA-2018-M-0411Hologic, IncAptima® HBV Quant Assay1/23/2018
    P160032, FDA-2018-M-0528Defibtech, LLCLifeline/ReviveR DDU-100, 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 Defibrillators2/1/2018
    P140003/S018, FDA-2018-M-0620Abiomed, IncImpella Ventricular Support Systems2/7/2018
    P160037, FDA-2018-M-0736Becton, Dickinson and CoBD Onclarity HPV Assay2/12/2018
    P150001/S021, FDA-2018-M-0737Medtronic MiniMed, IncMiniMed 630G System2/13/2018
    P160017/S017, FDA-2018-M-0738Medtronic MiniMed, IncMiniMed 670G System2/13/2018
    P960043/S097, FDA-2018-M-0792Abbott VascularPerclose ProGlide® Suture-Mediated Closure System2/16/2018
    P160007, FDA-2018-M-1371Medtronic MiniMed, IncGuardian Connect System3/8/2018
    H170002, FDA-2018-M-1215Kaneka Pharma America LLCLIPOSORBER® LA-15 System3/20/2018
    P160013, FDA-2018-M-1237TransMedics, IncOrgan Care System (OCSTM) Lung System3/22/2018
    P050006/S060, FDA-2018-M-1372W.L. Gore & Associates, IncGORE® CARDIOFORM Septal Occluder3/30/2018
    P160018/S001, FDA-2018-M-1446Foundation Medicine, IncFoundationFocusTM CDx BRCA LOH4/6/2018
    P150009, FDA-2018-M-1447Angel Medical Systems, IncAngelMed Guardian System4/9/2018
    P160052, FDA-2018-M-1581Parsagen Diagnostics, IncPartoSure Test4/11/2018
    P950039/S036, FDA-2018-M-1580Hologic, IncThinPrep Integrated Imager4/18/2018
    P140010/S037, FDA-2018-M-1634Medtronic Vascular, IncIN.PACTTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter4/19/2018
    P960009/S219, FDA-2018-M-1727Medtronic, IncMedtronic DBS System for Epilepsy4/27/2018
    P170035, FDA-2018-M-1791Bausch + Lomb, IncBausch + Lomb ULTRA (samfilcon A) Contact Lenses4/30/2018
    P170016, FDA-2018-M-1753Teva Pharmaceuticals USA, IncSYNOJOYNTTM5/8/2018
    P040024/S099, FDA-2018-M-1970Galderma Laboratories, LPRestylane® Lyft with Lidocaine5/18/2018
    P170013, FDA-2018-M-2118MicroVention, IncLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr5/30/2018
    P170039, FDA-2018-M-2119Clinical Research Consultants, IncCustomFlexTM Artificial Iris5/30/2018
    P910056/S027, FDA-2018-M-2237Bausch + Lomb, IncenVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)6/8/2018
    P150013/S009, FDA-2018-M-2269Dako North America, IncPD-L1 IHC 22C3 pharmDx6/12/2018
    P100006/S005, FDA-2018-M-2335BioMimetic Therapeutics, LLCAUGMENT® Injectable6/12/2018
    P170043, FDA-2018-M-2460Glaukos CorpiStent inject Trabecular Micro-Bypass System (Model G2-M-IS)6/21/2018
    Start Printed Page 57732
    P160017/S031, FDA-2018-M-2461Medtronic MiniMed, IncMiniMed 670G System6/21/2018
    P160048, FDA-2018-M-2463Senseonics, IncEversense Continuous Glucose Monitoring System6/21/2018
    P180008, FDA-2018-M-2462Tandem Diabetes Care, Inct:slim X2 Insulin Pump with Basal-IQ Technology6/21/2018
    P180002, FDA-2018-M-2571Pulmonx CorpZephyr® Endobronchial Valve System6/29/2018
    P160026, FDA-2018-M-2883Physio-Control, IncLIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-Ion 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 Monitor/Defibrillator)7/2/2018
    P170024, FDA-2018-M-2884Stryker NeurovascularSurpass Streamline Flow Diverter7/13/2018
    P170041, FDA-2018-M-2885Abbott Molecular, IncAbbott RealTi me IDH17/20/2018
    P160030/S017, FDA-2018-M-2886Abbott Diabetes Care IncFreeStyle Libre 14 Day Flash Glucose Monitoring System7/23/2018
    P160053, FDA-2018-M-2887Endomagnetics LtdMagtraceTM and Sentimag® Magnetic Localization System7/24/2018
    P170042, FDA-2018-M-2983C.R. Bard, IncCOVERATM Vascular Covered Stent7/30/2018
    P150048/S012, FDA-2018-M-3131Edwards Lifesciences LLCEdwards Pericardial Mitral Bioprosthesis, Model 11000M8/9/2018
    P170034, FDA-2018-M-3153Ivantis, IncHydrus® Microstent8/10/2018
    P150013/S011, FDA-2018-M-3212Dako North America, IncPD-L1 IHC 22C3 pharmDx8/16/2018
    P030016/S001, FDA-2018-M-3503STAAR Surgical CoVisian® TORIC ICL (Implantable Collamer® Lens)9/13/2018
    H170004, FDA-2018-M-3505BIOTRONIK, IncPK Papyrus Covered Coronary Stent System9/14/2018
    P180011, FDA-2018-M-3548Boston Scientific CorpELUVIATM Drug-Eluting Vascular Stent System9/18/2018

    II. Electronic Access

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

    Start Signature

    Dated: November 13, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2018-25071 Filed 11-15-18; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
11/16/2018
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2018-25071
Pages:
57730-57732 (3 pages)
Docket Numbers:
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, FD
PDF File:
2018-25071.pdf