Document ID: FDA-2016-M-0120-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2016-05-20T04:00Z

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31944-31945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11856]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA-
2016-M-0120, FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA-
2016-M-0803, FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA-
2016-M-0807, FDA-2016-M-0926, FDA-2016-M-0928]

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 Division of Dockets Management.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA-2016-M-0120, 
FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA-2016-M-0803, 
FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA-2016-M-0807, 
FDA-2016-M-0926, FDA-2016-M-0928 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 http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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

[[Page 31945]]

Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the 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 quarterly 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, 2016, through March 31, 
2016. 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 January 1, 2016,
                                             Through March 31, 2016
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          PMA No., Docket No.                   Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
H130006, FDA-2015-M-4950..............  Torax Medical, Inc.......  FENIX Continence Restoration       12/18/2015
                                                                    System.
H140005, FDA-2015-M-4948..............  ARUP Laboratories........  PDGFRB FISH for Gleevec            12/18/2015
                                                                    Eligibility in
                                                                    Myelodysplastic Syndrome/
                                                                    Myeloproliferative Disease
                                                                    (MDS/MPD).
H140006, FDA-2015-M-4949..............  ARUP Laboratories........  KIT D816V Mutation Detection       12/18/2015
                                                                    by PCR for Gleevec
                                                                    Eligibility in Aggressive
                                                                    Systemic Mastocytosis (ASM).
P130007/S004, FDA-2016-M-0120.........  Animas Corp..............  Animas Vibe System...........      12/24/2015
P900033/S042, FDA-2016-M-0121.........  Integra LifeSciences Corp  Integra Omnigraft Dermal             1/7/2016
                                                                    Regeneration Matrix and
                                                                    Integra Dermal Regeneration
                                                                    Template.
P080028, FDA-2016-M-0122..............  Storz Medical Ag.........  Storz Medical Duolith SD1            1/8/2016
                                                                    Shock Wave Therapy.
P150011, FDA-2016-M-0123..............  LivaNova Canada Corp.....  Perceval Sutureless Heart            1/8/2016
                                                                    Valve.
P150027, FDA-2016-M-0803..............  Dako North America, Inc..  PD-L1 IHC 28-8 pharmDx.......       1/23/2016
P150004, FDA-2016-M-0804..............  Spinal Modulation, Inc...  Axium Neurostimulator System.       2/11/2016
P150022, FDA-2016-M-0805..............  Rex Medical, L.P.........  Closer Vascular Sealing             2/12/2016
                                                                    System.
P120018, FDA-2016-M-0806..............  Sharps Terminator, LLC...  Sharps Terminator............       2/17/2016
P150005, FDA-2016-M-0807..............  Boston Scientific Corp...  Blazer Open-Irrigated               2/24/2016
                                                                    Ablation Catheter System.
P130009/S037, FDA-2016-M-0926.........  Edwards Lifesciences, LLC  SAPIEN XT Transcatheter Heart       2/29/2016
                                                                    Valve and Accessories.
P020004/S123, FDA-2016-M-0928.........  W.L. Gore & Associates,    GORE EXCLUDER Iliac Branch          2/29/2016
                                         Inc.                       Endoprosthesis.
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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 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11856 Filed 5-19-16; 8:45 am]
 BILLING CODE 4164-01-P