Document ID: FDA-2009-M-0317-0001
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2010-06-24T04:00Z

[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]               
[Page 36099-36100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn10-52]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-M-0317, FDA-2009-M-0369, FDA-2009-M-0370, FDA-
2009-M-0485, FDA-2009-M-0536, FDA-2009-M-0540]

 
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. FDA believes that 
this procedure expedites public notification of these actions because 
announcements can be placed on the Internet more quickly than they can 
be published in the Federal Register, and FDA believes that the 
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and

[[Page 36100]]

Cosmetic Act (the 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 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, 2009, through September 30, 
2009, and from October 1, 2009, through December 31, 2009. There were 
no denial actions during either 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 July 1, 2009, through December 31, 2009.
------------------------------------------------------------------------
 PMA No.  Docket                                               Approval
       No.            Applicant            Trade Name            Date
------------------------------------------------------------------------
P070022            Hologic, Inc.   ADIANA PERMANENT           July 6,
FDA-2009-M-0317                     CONTRACEPTION SYSTEM       2009
------------------------------------------------------------------------
P060008/S11        Boston          TAXUS LIBERTE LONG         July 13,
FDA-2009-M-0369     Scientific      PACLITAXEL ELUING STENT    2009
                    Corp.           SYSTEM
------------------------------------------------------------------------
P030050/S2         Sanofi          SCULPTRA AESTHETIC         July 28,
FDA-2009-M-0370     Aventis, LLC                               2009
------------------------------------------------------------------------
P080013            Confluent       DURASEAL XACT SEALANT      September
FDA-2009-M-0485     Surgical,       SYSTEM                     4, 2009
                    Inc.
------------------------------------------------------------------------
P080008            bioMerieux,     VIDAS FREE PSA RT (fPSA)   October 8,
FDA-2009-M-0536     Inc.            ASSAY                      2009
------------------------------------------------------------------------
P030042            Wright Medical  CONSERVE PLUS TOTAL        November
FDA-2009-M-0540     Technology,     RESURFACING HIP SYSTEM     3, 2009
                    Inc.
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: June 17, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for 
Devices and Radiological Health.
[FR Doc. 2010-15259 Filed 6-23-10; 8:45 am]
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