[Federal Register: November 6, 2002 (Volume 67, Number 215)]
[Notices]
[Page 67629-67631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no02-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 02M-0250, 02M-0203, 02M-0180, 02M-0218, 02M-0272, 02M-
0271, 02M-0145, 02M-0311, 02M-0172, 02M-0217, 02M-0179, 02M-0255, 02M-
0173, 02M-0235, 02M-0167, 02M-0174, 02M-0216, and 02M-0236]
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 Dockets Management Branch.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness to the Dockets Management Branch (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 January 1998, FDA revised 21 CFR 814.44(d) and 814.45(d) (63 FR
4571, January 30, 1998) to discontinue individual publication of PMA
approvals and denials in the Federal Register, providing instead to
post this information to FDA's home page at
[[Page 67630]]
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov on the Internet. In addition, 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. 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 following is a list of approved PMAs for which summaries of
safety and effectiveness were placed on the Internet in accordance with
the procedure described above from April 1, 2002, through June 30,
2002. 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 April 1, 2002, Through June 30, 2002
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PMA Number/Docket
No. Applicant Trade Name Approval Date
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P000008/02M-0250 BioEntrics Corp. LAP-BAND June 5, 2001.
Adjustable
Gastric Banding
System
P980033/02M-0203 Boston Scientific WALLSTENT November 16,
Scimed, Inc. Endoprosthesis 2001.
P010027/02M-0180 Ophthalmic ALLERGAN, INC. November 21,
Innovations Model AC 21B 2001.
International, Anterior
Inc. Chamber
Intraocular
Lens (Cataract)
P010033/02M-0218 Cellestis Ltd. QUANTIFERON-TB November 28,
2001.
P000049/02M-0272 Nitinol Medical CARDIOSEAL December 5,
Technologies, Septal 2001.
Inc. Occlusion
System With
QWIKLOAD
P000039/02M-0271 AGA Medical Corp. THE AMPLATZER December 5,
Septal Occluder 2001.
(ASO) And
AMPLATZER
Exchange System
P010030/02M-0145 Lifecor, Inc. Wearable December 18,
Cardioverter 2001.
Defibrillator
(WCD) 2000
``Lifevest''
System
H000002/02M-0311 VISX, Inc. VISX EXCIMER December 19,
LASER SYSTEM 2001.
AND CUSTOM
CONTOURED
ABLATION
PATTERN (C0-
CAP) METHOD
P980024(S1)/02M- Vysis PATHVYSION HER-2 December 31,
0172 DNA Probe Kit 2001.
P9600009(S7)/02M- Medtronic, Inc. MEDTRONIC ACTIVA January 14,
0217 Parkinson's 2002.
Control System
P010054/02M-0179 Roche Diagnostics ELECSYS ANTI-HBS February 28,
Co. Immunoassay 2002.
PRECICONTROL
ANTI02M-HBS
P000037(S1)/02M- Medical Carbon ON-X Prosthetic March 6, 2002.
0255 Research Heart Valve,
Institute, LLC Models ONXM and
ONXMC
P010025/02M-0173 Hologic, Inc. LORAD Digital March 15, 2002.
Breast Imager
P000033/02M-0235 SulzerIntra INTRACOIL Self- April 3, 2002.
Therapeutics, Expanding
Inc. Peripheral
Stent
H000007/02M-0167 AGA Medical Corp. AMPLATZER PFO April 5, 2002.
Occluder
P010018/02M-0174 Refractec, Inc. VIEWPOINT CK April 11, 2002.
SYSTEM
P900033(S8)/02M- Integra INTEGRA Dermal April 19, 2002.
0216 Lifesciences, Regeneration
Corp. Template
P010012/02M-0236 Guidant Corp. CONTAK CD/ May 2, 2002.
EASYTRAK Lead
System, Models
4510, 4511,
4512, And 4513
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[[Page 67631]]
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: October 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28155 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S