[Federal Register: December 19, 2007 (Volume 72, Number 243)]
[Notices]
[Page 71922]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de07-80]
[[Page 71922]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0285, 2007M-0286, 2007M-0287, 2007M-0288, 2007M-
0289, 2007M-0298, 2007M-0303, 2007M-0344]
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: Samie Allen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4013.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 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, 2007, through September 30,
2007. 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 July 1, 2007, through September 30, 2007
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PMA No./Docket Approval
No. Applicant Trade Name Date
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P040044(S1)/ Access Closure, MYNX VASCULAR CLOSURE May 16,
2007M-0285 Inc. DEVICE 2007
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P050016/2007M- Corin, USA CORMET HIP RESURFACING July 3,
0286 SYSTEM 2007
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P050039/2007M- Exactech, Inc. NOVATION CERAMIC July 5,
0287 ARTICULATION HIP SYSTEM 2007
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P930016(S25)/ VISX, Inc. STAR S4 IR EXCIMER LASER July 11,
2007M-0288 SYSTEM & WAVESCAN 2007
SYSTEM
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P060018/2007M- Medtronic Sofamor PRESTIGE CERVICAL DISC July 16,
0289 Danek, Inc. SYSTEM 2007
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P060002/2007M- C.R. Bard, Inc. FLAIR ENDOVASCULAR STENT July 23,
0298 GRAFT 2007
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P050024/2007M- Cryocor, Inc. CRYOCOR CRYOABLATION August 1,
0303 SYSTEM 2007
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P050043/2007M- Morris Innovative FEMORAL INTRODUCER August 20,
0344 Research, Inc. SHEATH & HEMOSTASIS 2007
(FISH) DEVICE 5, 6, & 8
FRENCH
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html.
Dated: December 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24620 Filed 12-18-07; 8:45 am]
BILLING CODE 4160-01-S