Document ID: FDA-2011-M-0323-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability
Posted Date: 2011-08-04T04:00Z

[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47210-47211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19734]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 
FDA-2011-M-0503]

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, 301-796-
6570.

SUPPLEMENTARY INFORMATION:

I. 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 http://www.fda.gov.
    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
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      PMA No./Docket No.               Applicant                   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.
                                 Inc.                    system.
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.
                                 Inc.
P090002 FDA-2011-M-0470.......  Depuy Orthopaedics,     Pinnacle complete acetabular hip  June 13, 2011.
                                 Inc.                    system.
P100027 FDA-2011-M-0472.......  Ventana Medical         INFORM HER2 dual ISH DNA probe    June 14, 2011.
                                 Systems, Inc.           cocktail.
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.
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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: July 29, 2011.
Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-19734 Filed 8-3-11; 8:45 am]
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