Medical Devices:


Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)


Pages 47210-47211

From the Federal Register Online via the Government Printing Office []

FR Doc No: 2011-19734


Food and Drug Administration

Docket Nos. FDA-2011-M-0323, FDA-2011-M-0256, FDA-2011-M-0257, FDA- 2011-M-0241, FDA-2011-M-0284, FDA-2011-M-0295, FDA-2011-M-0300, FDA- 2011-M-0296, FDA-2011-M-0342, FDA-2011-M-0338, FDA-2011-M-0343, FDA- 2011-M-0348, FDA-2011-M-0349, FDA-2011-M-0430, FDA-2011-M-0431, FDA- 2011-M-0445, FDA-2011-M-0470, FDA-2011-M-0472, FDA-2011-M-0502, and


Medical Devices; Availability of Safety and Effectiveness

Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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, 301-796- 6570.


  1. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the

    Federal Register. Instead, the Agency now posts this information on the

    Internet on FDA's home page at

    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

    Page 47211

    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 April 1, 2011, through June 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.

    Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2011, Through

    June 30, 2011

    PMA No./Docket No.


    Trade name

    Approval date

    P050050 FDA-2011-M-0323....... Small Bone

    Scandinavian total ankle

    May 27, 2009.

    Innovations, Inc.

    replacement system.

    P060004(S1) FDA-2011-M-0256... Carl Zeiss Meditec,

    Meditec MEL 80 excimer laser

    March 28, 2011.



    P100040 FDA-2011-M-0257....... Medtronic Vascular.... Valiant thoracic stent graft

    April 1, 2011. system.

    H100002 FDA-2011-M-0241....... NeuroVasx, Inc........ cPAX aneurysm treatment system.. April 1, 2011.

    P100018 FDA-2011-M-0284....... Chestnut Medical

    Pipeline embolization device.... April 6, 2011.

    Technologies, Inc.

    P100034 FDA-2011-M-0295....... NovoCure, Ltd......... NovoCure Ltd.'s NovoTTF-100A

    April 8, 2011. treatment kit.

    P100020 FDA-2011-M-0300....... Roche Molecular

    cobas HPV test.................. April 19, 2011.

    Systems, Inc.

    P100029 FDA-2011-M-0296....... St. Jude Medical, Inc. Trifecta heart valve............ April 20, 2011.

    P100023 FDA-2011-M-0342....... Boston Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire systems).

    P930014 (S45) FDA-2011-M-0338. Alcon Research, Ltd... AcrySof toric IOL and AcrySof IQ May 3, 2011. toric IOL.

    P040012 (S34) FDA-2011-M-0343. Abbott Vascular, Inc.. RX Acculink carotid stent system May 6, 2011.

    P090028 FDA-2011-M-0348....... Ortho-Clinical

    Vitros immunodiagnostic products May 11, 2011.

    Diagnostics, Inc.

    HBeAg reagent pack/products

    HBeAg calibrator/products HBe controls.

    P100017 FDA-2011-M-0349....... Abbott Molecular, Inc. Abbott RealTime HCV, Abbott

    May 17, 2011.

    RealTime HCV amplification reagent kit, Abbott RealTime

    HCV control kit, Abbott

    RealTime HCV calibrator kit, and optional UNG Uracil-N- glycosylase.

    P100013 FDA-2011-M-0430....... Cordis Corp........... Cordis ExoSeal vascular closure May 19, 2011. device.

    P070015 (S54) FDA-2011-M-0431. Abbott Vascular....... Xience nano everolimus-eluting

    May 24, 2011. coronary stent system and

    Promus everolimus-eluting coronary stent system.

    P100014 FDA-2011-M-0445....... Oceana Therapeutics,

    Solesta injectable gel.......... May 27, 2011.


    P090002 FDA-2011-M-0470....... Depuy Orthopaedics,

    Pinnacle complete acetabular hip June 13, 2011.



    P100027 FDA-2011-M-0472....... Ventana Medical

    INFORM HER2 dual ISH DNA probe

    June 14, 2011.

    Systems, Inc.


    P100031 FDA-2011-M-0502....... Roche Diagnostics Corp Elecsys anti-HBc immunoassay and June 22, 2011.

    Elecsys PreciControl anti-HBc for use on the modular

    Analytics E170 immunoassay analyzer.

    P100032 FDA-2011-M-0503....... Roche Diagnostics Corp Elecsys anti-HBc immunoassay and June 27, 2011.

    Elecsys PreciControl anti-HBc for use on the Elecsys 2010 immunoassay analyzer.

  2. Electronic Access

    Persons with access to the Internet may obtain the documents at

    Dated: July 29, 2011.

    Nancy K. Stade,

    Deputy Director for Policy, Center for Devices and Radiological


    FR Doc. 2011-19734 Filed 8-3-11; 8:45 am

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