[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36099-36100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15259]
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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.
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PMA No. Docket Approval
No. Applicant Trade Name Date
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P070022 Hologic, Inc. ADIANA PERMANENT July 6,
FDA-2009-M-0317 CONTRACEPTION SYSTEM 2009
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P060008/S11 Boston TAXUS LIBERTE LONG July 13,
FDA-2009-M-0369 Scientific PACLITAXEL ELUING STENT 2009
Corp. SYSTEM
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P030050/S2 Sanofi SCULPTRA AESTHETIC July 28,
FDA-2009-M-0370 Aventis, LLC 2009
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P080013 Confluent DURASEAL XACT SEALANT September
FDA-2009-M-0485 Surgical, SYSTEM 4, 2009
Inc.
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P080008 bioMerieux, VIDAS FREE PSA RT (fPSA) October 8,
FDA-2009-M-0536 Inc. ASSAY 2009
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P030042 Wright Medical CONSERVE PLUS TOTAL November
FDA-2009-M-0540 Technology, RESURFACING HIP SYSTEM 3, 2009
Inc.
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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: 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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