Document ID: FDA-2014-M-1597-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2015-04-22T04:00Z

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22527-22528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09298]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-1452, FDA-2014-M-1596, FDA-2014-M-1597, FDA-
2014-M-1599, FDA-2014-M-1735, FDA-2014-M-1736, FDA-2014-M-2042, FDA-
2014-M-2246, FDA-2014-M-2248, and FDA-2014-M-2376]

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: Submit written requests for copies of summaries of safety 
and effectiveness data to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. Please cite the appropriate docket number as listed in table 
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the summaries of safety and 
effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

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 October 1, 2014, through December 31, 
2014. 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 October 1, 2014,
                                            Through December 31, 2014
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         PMA No., Docket No.                  Applicant                Trade name             Approval date
----------------------------------------------------------------------------------------------------------------
P040037/S060, FDA-2014-M-1452........  W.L. Gore & Associates,  GORE VIABAHN             September 19, 2014.
                                        Inc.                     Endoprosthesis, GORE
                                                                 VIABAHN Endoprosthesis
                                                                 with Heparin.
P070015/S122, FDA-2014-M-1596........  Abbott Vascular, Inc...  XIENCE V[supreg] and     October 3, 2014.
                                                                 XIENCE nano[supreg]
                                                                 Everolimus Eluting
                                                                 Coronary Stent System.
P110019/S066, FDA-2014-M-1596........  Abbott Vascular, Inc...  XIENCE PRIME[supreg]     October 3, 2014.
                                                                 and XIENCE PRIME LL
                                                                 Everlimus Eluting
                                                                 Coronary Stent System.
P130024, FDA-2014-M-1597.............  Lutonix, Inc...........  Lutonix 035 Drug Coated  October 9, 2014.
                                                                 Balloon PTA Catheter.
P110023/S007, FDA-2014-M-1599........  ev3, Inc...............  EverFlexTM Self-         October 10, 2014.
                                                                 Expanding Peripheral
                                                                 Stent System.
P120005/S018, FDA-2014-M-1735........  Dexcom, Inc............  Dexcom G4TM PLATINUM     October 21, 2014.
                                                                 Continuous Glucose
                                                                 Monitoring System.
P130026, FDA-2014-M-1736.............  St. Jude Medical.......  TactiCath                October 24, 2014.
                                                                 Quartz[supreg]
                                                                 Catheter and
                                                                 TactiSysQuartz[supreg]
                                                                 Equipment.
P120011, FDA-2014-M-2042.............  Ideal Implant, Inc.....  IDEAL IMPLANT[supreg]    November 14, 2014.
                                                                 Saline-filled Breast
                                                                 Implant.
P130007, FDA-2014-M-2246.............  Animas Corp............  Animas Vibe System.....  November 25, 2014.
P140020, FDA-2014-M-2248.............  Myriad Genetic           BRACAnalysis CDxTM.....  December 19, 2014.
                                        Laboratories, Inc.
P020012/S009, FDA-2014-M-2376........  Suneva Medical, Inc....  Bellafill..............  December 23, 2014.
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[[Page 22528]]

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: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09298 Filed 4-21-15; 8:45 am]
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