Document ID: FDA-2014-M-0875-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2015-02-11T05:00Z

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7615-7616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02783]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-0867, FDA-2014-M-0874, FDA-2014-M-0875, FDA-
2014-M-1060, FDA-2014-M-1064, FDA-2014-M-1113, FDA-2014-M-1114, FDA-
2014-M-1193, FDA-2014-M-1265, FDA-2014-M-1279, and FDA-2014-M-1280]

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 July 1, 2014, through September 30, 
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 July 1, 2014, Through
                                               September 30, 2014
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        PMA No., Docket No.                Applicant              Trade name               Approval date
----------------------------------------------------------------------------------------------------------------
P130021/S002, FDA-2014-M-0867......  Medtronic CoreValve    Medtronic CoreValveTM  June 12, 2014.
                                      LLC.                   System (MCS).
P130009, FDA-2014-M-0874...........  Edwards Lifesciences,  Edwards SAPIEN XTTM    June 16, 2014.
                                      LLC.                   Transcatheter Heart
                                                             Valve and
                                                             Accessories.
P130029, FDA-2014-M-0875...........  Bard Peripheral        Fluency[supreg] Plus   June 17, 2014.
                                      Vascular, Inc.         Endovascular Stent
                                                             Graft.
P130011, FDA-2014-M-1064...........  Sorin Group Canada,    Freedom SOLO           June 24, 2014.
                                      Inc.                   Stentless Heart
                                                             Valve and SOLO Smart
                                                             Heart Valve.
P130030, FDA-2014-M-1060...........  Boston Scientific      REBELTM Platinum       June 27, 2014.
                                      Corp.                  Chromium Coronary
                                                             Stent System
                                                             (MonorailTM and Over-
                                                             The-Wire).
P090029, FDA-2014-M-1113...........  Medtronic Sofamor      Prestige[supreg] LP    July 24, 2014.
                                      Danek USA, Inc.        Cervical Disc.
H130005, FDA-2014-M-1114...........  MicroVention, Inc....  Low-Profile            July 25, 2014.
                                                             Visualized
                                                             Intraluminal Support
                                                             Device (LVIS and
                                                             LVIS Jr.).
P130017, FDA-2014-M-1193...........  Exact Sciences, Inc..  COLOGUARDTM..........  August 11, 2014.
H120003, FDA-2014-M-1265...........  XVIVO Perfusion, Inc.  XVIVO Perfusion        August 12, 2014.
                                                             System (XPSTM) with
                                                             STEEN SolutionTM
                                                             Perfusate.
H130004, FDA-2014-M-1280...........  Plexision, Inc.......  PleximmuneTM.........  August 26, 2014.
P130020, FDA-2014-M-1279...........  GE Healthcare........  SenoClaire...........  August 26, 2014.
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[[Page 7616]]

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: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02783 Filed 2-10-15; 8:45 am]
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