Document ID: FDA-2011-M-0034-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability
Posted Date: 2011-06-02T04:00Z

[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Notices]
[Pages 31965-31966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-
2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-
2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and 
FDA-2011-M-0198]

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 the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that amended 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 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 January 1, 2011, through March 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 January 1, 2011,
                                             Through March 31, 2011
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        PMA No. Docket No.              Applicant              Trade name                  Approval date
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P010012 (S230)...................  Boston Scientific    BOSTON SCIENTIFIC         September 16, 2010.
                                    Corp.                CARDIAC
                                                         RESYNCHRONIZATION
                                                         THERAPY DEFIBRILLATORS.
FDA-2011-M-0034
P100021..........................  Medtronic Vascular.  MEDTRONIC VASCULAR        December 16, 2010.
                                                         ENDURANT STENT GRAFT
                                                         SYSTEM.
FDA-2011-M-0040
P100010..........................  Medtronic Cryocath,  ARCTIC FRONT              December 17, 2010.
                                    LP.                  CRYOCATHETER SYSTEM.
FDA-2011-M-0041
P070014 (S10)....................  Bard Peripheral      LIFESTENT AND LIFESTENT   December 23, 2010.
                                    Vascular.            LX VASCULAR STENT
                                                         SYSTEMS.
FDA-2011-M-0039
P070026..........................  Depuy, Inc.........  CERAMAX CERAMIC HIP       December 23, 2010.
                                                         SYSTEM.
FDA-2011-M-0035
P100028..........................  Cook Medical, Inc..  FORMULA BALLOON-          January 14, 2011.
                                                         EXPANDABLE RENAL STENT
                                                         SYSTEM.
FDA-2011-M-0056
P090013..........................  Medtronic, Inc.....  REVO MRI SURESCAN IPG     February 8, 2011.
                                                         AND PACING SYSTEM.
FDA-2011-M-0105
P080003..........................  Hologic, Inc.......  SELENIA DIMENSIONS 3D     February 11, 2011.
                                                         SYSTEMS.
FDA2011-M-0131
P080027 (S1).....................  OraSure              ORAQUICK HCV RAPID        February 18, 2011.
                                    Technologies, Inc.   ANTIBODY TEST.
FDA-2011-M-0132
H080005..........................  Elana, Inc.........  ELANA SURGICAL KIT HUD..  March 10, 2011.
FDA-2011-M-0170
P080025..........................  Medtronic            MEDTRONIC INTERSTIM       March 14, 2011.
                                    Neuromodulation.     THERAPY SYSTEM.
FDA-2011-M-0175

[[Page 31966]]

 
P80020...........................  Seikagaku Corp.....  GEL-ONE.................  March 22, 2011.
FDA-2011-M-0198
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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: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices and Radiological Health.
[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]
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