[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50826-50827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0084, FDA-2008-M-0100 (formerly 2008M-0013),
FDA-2008-M-0182, FDA-2008-M-0109, FDA-2008-M-0207]
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://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 January 1, 2008, through March 31,
2008. 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, 2008, through March 31, 2008
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PMA No. Docket Approval
No. Applicant TRADE NAME Date
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P040021 (S004) St. Jude SJM EPIC VALVE AND SJM November 15,
FDA-2008-M-0084 Medical, Inc. SUPRA VALVE 2007
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[[Page 50827]]
P070001 Synthes Spine, PRODISC-C TOTAL DISC December 17,
FDA-2008-M-0100 Inc. PEPLACEMENT 2007
(formerly 2008M-
0013)
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P050045 Dako Denmark a/ DAKO TOP2A FISH PHARM DX January 11,
FDA-2008-M-0182 s KIT 2008
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P060033 Medtronic ENDEAVOR ZOTAROLIMUS- February 1,
FDA-2008-M-0109 Vascular ELUTING CORONARY STENT 2008
ON THE OVER THE WIRE
(OTW), RAPID EXCHANGE
(RX), OR MULTI-EXHANGE
II (MX\2\) STENT
DELIVERY SYSTEM
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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: August 14, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-19907 Filed 8-27-08; 8:45 am]
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