Document ID: FDA-2014-M-0434-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2014-09-26T04:00Z

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57940-57941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22987]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-0327, FDA-2014-M-0434, FDA-2014-M-0552, FDA-
2014-M-0553, FDA-2014-M-0690; FDA-2014-M-0691, FDA-2014-M-0692, FDA-
2014-M-0726, FDA-2014-M-0727, FDA-2014-M-0866, and FDA-2014-M-0872]

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

[[Page 57941]]

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 (21 
U.S.C. 360e(g)). 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 April 1, 2014, through June 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 April 1, 2014, Through
                                                  June 30, 2014
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         PMA No., Docket No.                  Applicant                Trade name             Approval date
----------------------------------------------------------------------------------------------------------------
P130016, FDA-2014-M-0327.............  Cochlear Americas......  Nucleus[supreg]          March 20, 2014.
                                                                 Hybrid\TM\ L24
                                                                 Cochlear Implant
                                                                 System.
P120020, FDA-2014-M-0434.............  Abbott Vascular (IDEV    SUPERA[supreg]           March 28, 2014.
                                        Technologies, Inc.).     Peripheral Stent
                                                                 System.
P010015/S205, FDA-2014-M-0553........  Medtronic, Inc.........  Cardiac                  April 10, 2014.
                                                                 Resynchronization
                                                                 Therapy Pacemaker (CRT-
                                                                 P) Devices.
P010031/S381, FDA-2014-M-0553........  Medtronic, Inc.........  Cardiac                  April 10, 2014.
                                                                 Resynchronization
                                                                 Therapy Defibrillator
                                                                 (CRT-D) Devices.
P100020/S008, FDA-2014-M-0552........  Roche Molecular          cobas[supreg] HPV Test.  April 24, 2014.
                                        Systems, Inc.
P130008, FDA-2014-M-0690.............  Inspire Medical          Inspire Upper Airway     April 30, 2014.
                                        Systems, Inc.            Stimulation (UAS)
                                                                 system.
P110005, FDA-2014-M-0691.............  IBSA Institut            Gel-Syn\TM\ Sinovial     May 9, 2014.
                                        Biochimique SA.          (Sodium Hyaluronate
                                                                 0.8%).
P110041, FDA-2014-M-0692.............  Siemens Healthcare       ADVIA Centaur[supreg]    May 16, 2014.
                                        Diagnostics.             HBsAgII, ADVIA
                                                                 Centaur[supreg] HBsAg
                                                                 Confirmatory and ADVIA
                                                                 Centaur[supreg] HBsAg
                                                                 Quality Control
                                                                 Material.
P110027, FDA-2014-M-0726.............  QIAGEN Manchester Ltd..  therascreen[supreg]      May 23, 2014.
                                                                 KRAS RGQ PCR Kit.
P100045, FDA-2014-M-0727.............  CardioMEMS, Inc........  CardioMEMS\TM\ HF        May 28, 2014.
                                                                 System.
P130027, FDA-2014-M-0866.............  QIAGEN, Inc............  artus[supreg] CMV RGQ    June 2, 2014.
                                                                 MDx Kit.
P040024/S072, FDA-2014-M-0872........  Valeant Pharmaceuticals  Restylane Silk           June 13, 2014.
                                        North America LLC/       Injectable Gel.
                                        Medicis.
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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 23, 2014
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22987 Filed 9-25-14; 8:45 am]
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