[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57560-57561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-0326, FDA-2013-M-1324, FDA-2013-M-1693, FDA-
2014-M-0069, FDA-2014-M-0166, FDA-2014-M-0167, FDA-2014-M-0224, and 
FDA-2014-M-0254]


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 January 1, 2014, through March 31, 
2014, and includes one denial action 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, 2014,
                                             Through March 31, 2014
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         PMA No., Docket No.                  Applicant                Trade name             Date of action
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P070023, FDA-2013-M-1324.............  Fzio Med, Inc..........  Oxiplex[reg]/SP Gel....  Denied October 21,
                                                                                          2013.
P110016/S008, FDA-2013-M-1693........  St. Jude Medical, Inc..  Therapy Cool Flex        Approved December 18,
                                                                 Ablation Catheter.       2013.
P130004, FDA-2014-M-0069.............  Ocular Therapeutics,     ReSure[reg] Sealant....  Approved January 8,
                                        Inc.                                              2014.
P130021, FDA-2014-M-0166.............  Medtronic CoreValve LLC  Medtronic CoreValveTM    Approved January 17,
                                                                 System.                  2014.
P100040/S012, FDA-2014-M-0167........  Medtronic Vascular.....  Valiant Thoracic Stent   Approved January 22,
                                                                 Graft with Captivia      2014.
                                                                 Delivery System.
P120005/S002, FDA-2014-M-0224........  Dexcom, Inc............  Dexcom G4 PLATINUM       Approved February 3,
                                                                 (Pediatric) Continuous   2014.
                                                                 Glucose Monitoring
                                                                 System.

[[Page 57561]]

 
P090031, FDA-2014-M-0254.............  Anika Therapeutics, Inc  MONOVISCTM Injectable    Approved February 25,
                                                                 Intra-articular Device.  2014.
P130015, FDA-2013-M-0326.............  Roche Diagnostics        Elecsys[reg] HBeAg       Approved March 14,
                                        Operations, Inc.         Immunoassay and          2014.
                                                                 Elecsys[reg]
                                                                 PreciControl HBeAg.
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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: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22807 Filed 9-24-14; 8:45 am]
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