Document ID: FDA-2017-M-6984-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2018-11-16T05:00Z

[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]

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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.

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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: 

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
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              PMA No., Docket No.                                     Applicant                                    Trade name              Approval date
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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.
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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