[Federal Register: May 7, 2004 (Volume 69, Number 89)]
[Notices]
[Page 25594-25595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003M-0532, 2003M-0487, 2003M-0488, 2003M-0499, 2003M-
0490, 2003M-0491, 2003M-0492, 2003M-0533, 2003M-0524, 2003M-0536,
2003M-0569, 2003M-0560]
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 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: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
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
[[Page 25595]]
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 October 1, 2003, through December 31,
2003. 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 October 1, 2003, through December 31, 2003
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P000028/2003M- Medtronic, Inc. AFFINITY CAGE June 13, 2002
0532 (Sofamor Danek) SYSTEM
(INTERVERTEBRAL
CERVICAL
DEVICE)
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P020007/2003M- Medtronic AVE, MEDTRONIC AVE December 18,
0487 Inc. BRIDGE EXTRA 2002
SUPPORT OVER-
THE-WIRE RENAL
STENT SYSTEM
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P020041/2003M- Femcap, Inc. FEMCAP BARRIER March 28, 2003
0488 CONTRACEPTIVE
DEVICE
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P020047/2003M- Guidant Corp. MULTI-LINK RX/ July 16, 2003
0499 OTW VISION
CORONARY STENT
SYSTEM
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P030009/2003M- Medtronic DRIVER OVER-THE- October 1, 2003
0490 Vascular WIRE, RAPID
EXCHANGE, AND
MULTI-EXCHANGE
CORONARY STENT
SYSTEM
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P020050/2003M- Wavelight Laser WAVELIGHT October 7, 2003
0491 Technologies ALLEGRETTO WAVE
(SurgiVision EXCIMER LASER
Refractive SYSTEM
Consultants,
LLC)
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P030008/2003M- Wavelight Laser WAVELIGHT October 10, 2003
0492 Technologies ALLEGRETTO WAVE
(SurgiVision EXCIMER LASER
Refractive SYSTEM
Consultants,
LLC)
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P9900027(S6)/ Bausch & Lomb BAUSCH & LOMB October 10, 2003
2003M-0533 Surgical, Inc. TECHNOLAS 217Z
ZYOPTIX SYSTEM
FOR
PERSONALIZED
VISION
CORRECTION
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P020040/2003M- Medinol Ltd. NIRFLEX PRE- October 24, 2003
0524 MOUNTED
CORONARY STENT
SYSTEM
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H020003/2003M- Medtronic, Inc. CONTEGRA November 21,
0536 PULMONARY 2003
VALVED CONDUIT
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D980003/2003M- Encore Medical, KERAMOS CERAMIC/ November 26,
0569 LP CERAMIC TOTAL 2003
HIP SYSTEM
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P030039/2003M- Baxter Bio COSEAL SURGICAL December 12,
0560 Science (Baxter SEALANT 2003
Healthcare)
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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: April 26, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-10459 Filed 5-6-04; 8:45 am]
BILLING CODE 4160-01-S