Document ID: FDA-2017-M-3990-0003
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2018-05-22T04:00Z

[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23686-23688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-
2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-
2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-
2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-
2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-
2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-
2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-
2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-
2017-M-6800, and FDA-2017-M-6896]

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) 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: httpss://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-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, 
FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, 
FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, 
FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, 
FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, 
FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, 
FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, 
FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and 
FDA-2017-M-6896 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.
    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.

[[Page 23687]]

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 July 1, 2017, through December 31, 2017. 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 July 1, 2017, Through
                                                December 31, 2017
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                   Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P160015, FDA-2017-M-3372..............  Zoll Medical Corporation.  AED Plus[supreg] and Fully          5/26/2017
                                                                    Automatic AED Plus[supreg].
P970003/S207, FDA-2017-M-3951.........  Cyberonics, Inc..........  VNS Therapy System...........       6/23/2017
P150048, FDA-2017-M-3990..............  Edwards Lifesciences, LLC  Edwards Pericardial Aortic          6/29/2017
                                                                    Bioprosthesis and Edwards
                                                                    INSPIRIS RESILIA Aortic
                                                                    Valve.
P930016/S048, FDA-2017-M-4022.........  AMO Manufacturing USA,     STAR S4 IR Excimer Laser            6/30/2017
                                         LLC.                       System and iDesign Advanced
                                                                    WaveScan Studio System.
P130021/S033, FDA-2017-M-4271.........  Medtronic CoreValve LLC..  Medtronic CoreValveTM System,       7/10/2017
                                                                    Medtronic CoreValveTM
                                                                    EvolutTM R System and
                                                                    Medtronic CoreValveTM
                                                                    EvolutTM PRO Systems.
P160049, FDA-2017-M-4498..............  Spectranetics Corp.......  Stellarex 0.035'' OTW Drug-         7/26/2017
                                                                    coated Angioplasty Balloon.
P170006, FDA-2017-M-4756..............  Medtronic, Inc...........  AvalusTM Bioprosthesis.......       7/31/2017
P170005, FDA-2017-M-4757..............  Abbott Molecular, Inc....  Abbott RealTime IDH2.........        8/1/2017
P160042, FDA-2017-M-4711..............  Prollenium Medical         Ravanesse Ultra..............        8/4/2017
                                         Technologies, Inc.
P030017/S275, FDA-2017-M-4904.........  Boston Scientific          PrecisionTM Spinal Cord             8/11/2017
                                         Neuromodulation            Stimulator System, Precision
                                         Corporation.               SpectraTM Spinal Cord
                                                                    Stimulator System,
                                                                    PrecisionTM NoviTM Spinal
                                                                    Cord Stimulator System,
                                                                    PrecisionTM MontageTM MRI
                                                                    Spinal Cord Stimulator
                                                                    System, PrecisionTM
                                                                    MontageTM Spinal Cord
                                                                    Stimulator System and
                                                                    Spectra WaveWriterTM Spinal
                                                                    Cord Stimulator System.
P160054, FDA-2017-M-5320..............  Thoratec Corporation.....  HeartMate 3TM Left                  8/23/2017
                                                                    Ventricular Assist System.
P140015/S020, FDA-2017-M-5262.........  Tandem Diabetes Care, Inc  t:slim X2 Insulin Pump with         8/25/2017
                                                                    Dexcom G5 Mobile CGM.
P170003, FDA-2017-M-5334..............  Lutonix, Inc.............  Lutonix[supreg] 035 Drug            8/25/2017
                                                                    Coated Balloon PTA Catheter,
                                                                    Model 9010.
P170007, FDA-2017-M-5438..............  Bioventus LLC............  DUROLANE[supreg].............       8/29/2017
P150025/S003, FDA-2017-M-5813.........  Dako North America, Inc..  PD-L1 IHC 28-8 pharmDx.......       9/15/2017
P150042, FDA-2017-M-5863..............  ZEUS Scientific, Inc.....  ZEUS ELISA Parvovirus B19 IgM       9/19/2017
                                                                    Test System.
P150045, FDA-2017-M-5864..............  ZEUS Scientific, Inc.....  ZEUS ELISA Parvovirus B19 IgG       9/19/2017
                                                                    Test System.
P170011, FDA-2017-M-5884..............  ABIOMED, Inc.............  Impella RP[supreg] System....       9/20/2017
P150013/S006, FDA-2017-M-5929.........  Dako North America, Inc..  PD-L1 IHC 22C3 pharmDx.......       9/22/2017
P160030, FDA-2017-M-5969..............  Abbott Diabetes Care, Inc  Freestyle Libre Flash Glucose       9/27/2017
                                                                    Monitoring System.
P100047/S090, FDA-2017-M-5968.........  Medtronic, Inc...........  HeartWareTM HVADTM System....       9/27/2017
P100021/S063, FDA-2017-M-5997.........  Medtronic Vascular.......  Endurant II/Endurant IIs            9/29/2017
                                                                    Stent Graft System.
P160039, FDA-2017-M-6223..............  Respicardia, Inc.........  remed[emacr][supreg] System..       10/6/2017
P170002, FDA-2017-M-6232..............  Teoxane S.A..............  RHA[supreg] 2, RHA[supreg] 3       10/19/2017
                                                                    and RHA[supreg] 4.
P150028/S001, FDA-2017-M-6290.........  NuMED, Inc...............  Cheatham Platinum (CP) Stent       10/24/2017
                                                                    System (Covered CP Stent,
                                                                    Model 427; Covered Mounted
                                                                    (CP) Stent, Model 428; CP
                                                                    Stent, Model 425; Mounted CP
                                                                    Stent, Model 426).
H020002/S046, FDA-2017-M-6524.........  Stryker Neurovascular....  Neuroform AtlasTM Stent             11/2/2017
                                                                    System.
P160057, FDA-2017-M-6525..............  OrthogenRx, Inc..........  TriVisc......................      11/13/2017
P160043/S001, FDA-2017-M-6550.........  Medtronic Vascular.......  Resolute OnyxTM Zotarolimus-       11/16/2017
                                                                    Eluting Coronary Stent
                                                                    System.
P160055, FDA-2017-M-6614..............  RxSight, Inc.............  Light Adjustable Lens (LAL)        11/22/2017
                                                                    and Light Delivery Device
                                                                    (LDD).
P170008, FDA-2017-M-6650..............  Medinol Ltd..............  EluNIR[supreg] Ridaforolimus       11/28/2017
                                                                    Eluting Coronary Stent
                                                                    System.
P170019, FDA-2017-M-6799..............  Foundation Medicine, Inc.  FoundationOne CDx............      11/30/2017

[[Page 23688]]

 
P150031, FDA-2017-M-6800..............  Boston Scientific          Vercise Deep Brain                  12/8/2017
                                         Corporation.               Stimulation (DBS) System.
P170012, FDA-2017-M-6896..............  Biom'Up SA...............  HEMOBLASTTM Bellows..........      12/15/2017
----------------------------------------------------------------------------------------------------------------

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: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10924 Filed 5-21-18; 8:45 am]
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