Document ID: FDA-2011-M-0737-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2012-03-16T04:00Z

[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15779-15780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M-0737, FDA-
2011-M-0746, FDA-2011-M-0786, FDA-2011-M-0791, FDA-2011-M-0792, FDA-
2011-M-0796, FDA-2011-M-0832, FDA-2011-M-0837, FDA-2011-M-0848, FDA-
2011-M-0865, FDA-2011-M-0866, FDA-2011-M-0910, and FDA-2011-M-0917]

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.

[[Page 15780]]

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 October 1, 2011, through December 31, 
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.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2011,
                                            Through December 31, 2011
----------------------------------------------------------------------------------------------------------------
        PMA No., Docket No.               Applicant             Trade name                Approval date
----------------------------------------------------------------------------------------------------------------
P110003, FDA-2011-M-0746..........  Pluromed, Inc........  LEGOO...............  September 28, 2011.
P090024, FDA-2011-M-0737..........  Siemens Healthcare     ADVIA CENTAUR HBEAG   October 11, 2011.
                                     Diagnostics.           assay and quality
                                                            control material.
P040024 (S51), FDA-2011-M-0735....  Medicis Aesthetics,    RESTYLANE injectable  October 11, 2011.
                                     Inc.                   gel.
P010029 (S8), FDA-2011-M-0736.....  Ferring                EUFLEXXA (1% sodium   October 11, 2011.
                                     Pharmaceuticals, Inc.  hyaluronate).
P110022, FDA-2011-M-0786..........  Roche Diagnostics      ELECSYS anti-HBC IGM  October 26, 2011.
                                     Corp.                  immunoassay and
                                                            ELECSYS
                                                            PRECICONTROL anti-
                                                            HBC IGM.
P110011, FDA-2011-M-0791..........  Medtronic Ireland....  ASSURANT COBALT       October 26, 2011.
                                                            iliac balloon-
                                                            expandable stent
                                                            system.
P100042, FDA-2011-M-0792..........  Gen-Probe              APTIMA HPV assay....  October 28, 2011.
                                     Incorporated.
P110019, FDA-2011-M-0796..........  Abbott Vascular......  XIENCE PRIME and      November 1, 2011.
                                                            XIENCE PRIME LL
                                                            EVEROLIMUS-eluting
                                                            coronary stent
                                                            system.
P100041, FDA-2011-M-0837..........  Edwards Lifesciences,  EDWARDS SAPIEN        November 2, 2011.
                                     LLC.                   transcatheter heart
                                                            valve and RETROFLEX
                                                            3 delivery system,
                                                            RETROFLEX balloon
                                                            catheter and
                                                            crimper.
P090016, FDA-2011-M-0832..........  Merz Aesthetics, Inc.  BELOTERO balance....  November 14, 2011.
H090002, FDA-2011-M-0848..........  BSD Medical Corp.....  BSD-2000              November 18, 2011.
                                                            hyperthermia system.
P110010, FDA-2011-M-0865..........  Boston Scientific      PROMUS ELEMENT PLUS   November 22, 2011.
                                     Corp.                  EVEROLIMUS-eluting
                                                            platinum chromium
                                                            coronary stent
                                                            system.
P100024, FDA-2011-M-0866..........  Dako Denmark A/S.....  HER2 CISH PHARMDX     November 30, 2011.
                                                            kit.
P110025, FDA-2011-M-0917..........  Roche Diagnostics      ELECSYS anti-HBC IGM  December 14, 2011.
                                     Corp.                  immunoassay and
                                                            ELECSYS
                                                            PRECICONTROL anti-
                                                            HBC IGM for use on
                                                            the MODULAR
                                                            ANALYTICS E170
                                                            immunoassay analyze.
P100046, FDA-2011-M-0910..........  AtriCure Inc.........  ATRICURE SYNERGY      December 14, 2011.
                                                            ablation system.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm; and
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.

    Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am]
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