[Federal Register: January 15, 2002 (Volume 67, Number 10)]
[Notices]
[Page 1980-1981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja02-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 01M-0271, 01M-0255, 01M-0210, 01M-0173, 01M-0254, 01M-
0227, 01M-0226, and 01M-0270]
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 the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule to revise Secs. 814.44(d) and 814.45(d) (21 CFR
814.44(d) and 814.45(d)) to discontinue publication of individual PMA
approvals and denials in the Federal Register. Instead, revised
Secs. 814.44(d) and 814.45(d) state that FDA will notify the public of
PMA approvals and denials by posting them on FDA's home page on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov, by placing the summaries of safety and
effectiveness on the Internet and in FDA's Dockets Management Branch,
and by publishing in the Federal Register after each quarter a list of
available safety and effectiveness summaries of approved PMAs and
denials announced in 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
[[Page 1981]]
and effectiveness were placed on the Internet in accordance with the
procedure explained previously from April 1, 2001, through June 30,
2001. 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, 2001, Through
June 30, 2001
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PMA Number/Docket No. Applicant Trade Name Approval Date
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P990086/01M-0271 HealthTronics, Inc. HealthTronics OssaTron October 12, 2000
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P000023/01M-0255 TMJ Implants, Inc. TMJ Fossa-Eminence/Condylar Prosthesis January 5, 2001
System\TM\
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P000035/01M-0210 TMJ Implants, Inc. TMJ Fossa-Eminence Prosthesis\TM\ February 27, 2001
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P990080/01M-0173 Pharmacia & Upjohn Co. CeeOn\TM\ Edge Foldable Ultraviolet Light- April 5, 2001
Absorbing Posterior Chamber Intraocular
Lens, Model 911A
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P980050(S1)/01M-0254 Medtronic, Inc. Medtronic Model 7350 April 6, 2001
Jewel AF Implantable
Cardioverter Defibrillator System,
Medtronic Model 9465 InCheck\TM\ Patient
Assistant, and Medtronic
Transvene CS/SVC Model 6937A
Lead
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P000046/01M-0227 Anika Therapeutics, Staar Surgical Co. STAARVISC\TM\ II April 18, 2001
Inc. Sodium Hyaluronate
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P000044/01M-0226 Ortho-Clinical Vitros Immunodiagnostic Products HBsAg April 27, 2001
Diagnostics, Inc. Reagent Pack, HBsAg Confirmatory Kit,
and HBsAg Calibrator
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P000037/01M-0270 Medical Carbon ON-X Prosthetic Heart Valve, May 30, 2001
Research Institute, Model ONXA
LLC.
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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 31, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-901 Filed 1-14-02; 8:45 am]
BILLING CODE 4160-01-S