Document ID: FDA-2011-M-0564-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability
Posted Date: 2012-01-13T05:00Z

[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2071-2072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-537]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0502, FDA-2011-M-0503, FDA-2011-M-0563, FDA-
2011-M-0564, FDA-2011-M-0600, FDA-2011-M-0601, FDA-2011-M-0630, and 
FDA-2011-M-0707]

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 of this document 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 section 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, 2011, through September 30, 
2011. 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.

[[Page 2072]]

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2011, Through
                                               September 30, 2011
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      PMA No. Docket No.            Applicant                 Trade name                    Approval date
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P100031, FDA-2011-M-0502......  Roche Diagnostics  ELECSYS ANTI-HBC IMMUNOASSAY &    June 22, 2011.
                                 Corp..             ELECSYS PRECICONTROL ANTI-HBC.
P100032, FDA-2011-M-0503......  Roche Diagnostics  ELECSYS ANTI-HBC IMMUNOASSAY,     June 27, 2011.
                                 Corp..             ELECSYS PRECICONTROL ANTI-HBC
                                                    FOR USE ON THE ELECSYS 2010
                                                    IMMUNOASSAY ANALYZER.
P100001, FDA-2011-M-0563......  Ortho-Clinical     VITROS IMMUNODIAGNOSTICS          July 20, 2011.
                                 Diagnostics,       PRODUCTS ANTI-HBE REAGENT PACK,
                                 Inc..              VITROS IMMUNODIAGNOSTIC
                                                    PRODUCTS ANTI-HBE CALIBRATOR,
                                                    AND VITROS IMMUNODIAGNOSTIC
                                                    PRODUCTS ANTI-HBE CONTROLS.
P110001, FDA-2011-M-0564......  Abbott Vascular..  RX HERCULINK ELITE RENAL STENT    July 20, 2011.
                                                    SYSTEM.
P100044, FDA-2011-M-0600......  Intersect ENT....  PROPEL..........................  August 11, 2011.
P110020, FDA-2011-M-0601......  Roche Molecular    COBAS 4800 BRAF V600 MUTATION     August 17, 2011.
                                 Systems, Inc..     TEST.
P110012, FDA-2011-M-0630......  Abbott Molecular,  VYSIS ALK BREAK APART FISH PROBE  August 26, 2011.
                                 Inc..              KIT; VYSIS PARAFFIN
                                                    PRETREATMENT IV & POST
                                                    HYBRIDIZATION WASH BUFFER KIT;
                                                    PROBECHEK ALK NEGATIVE CONTROL
                                                    SLIDES; AND PROBECHEK ALK
                                                    POSITIVE CONTROL SLIDES.
H100006, FDA-2011-M-0707......  Synapse            NEURX DPS DIAPHRAGM PACING        September 28, 2011.
                                 Biomedical, Inc..  SYSTEM.
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: January 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-537 Filed 1-12-12; 8:45 am]
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