FR Doc 04-21873

[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Notices]
[Page 58446-58448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-92]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004M-0147, 2004M-0145, 2004M-0207, 2004M-0253, 2004M-
0165, 2004M-0200, 2004M-0199, 2004M-0256, 2004M-0248, 2004M-0249,
2004M-0250, 2004M-0260, and 2004M-0259]

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

[[Page 58447]]

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 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 April 1, 2004, through June 30, 2004.
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 April 1, 2004 through June 30, 2004.
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P890064(S9)/ Digene DIGENE HYBRID March 31, 2003
2004M-0147 Diagnostics, CAPTURE 2 (HC2)
Inc. HIGH-RISK HPV DNA
TEST
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P020006/2004M- Enteric Medical ENTERYX PROCEDURE April 22, 2003
0145 Technologies, KIT
Inc.
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P970027/2004M- Abbott ABBOTT AXSYM February 5,
0207 Laboratories ANTIBODY TO HCV 2004
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P980007/2004M- Abbott AXSYM FREE PSA February 5,
0253 Laboratories 2004
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H020008/2004M- Stryker Biotech OP-1 PUTTY April 7, 2004
0165
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P010014/2004M- Biomet, Inc. OXFORD MENISCAL April 21, 2004
0200 UNICOMPARTMENTAL
KNEE SYSTEM
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P030032/2004M- Genzyme HYLAFORM (HYLAN B April 22, 2004
0199 Biosurgery GEL)
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P030017/2004M- Advanced Bionics Precision Spinal April 27, 2004
0256 Corp. Cord Stimulation
(SCS) System
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P030023/2004M- Ophtec USA, Inc. OCULAID/STABLEYES April 27, 2004
0248 CAPULAR TENSION
RINGS
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P000054/2004M- Wyeth INFUSE BONE GRAFT April 30, 2004
0249 Pharmaceuticals
, Inc.
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P030035/2004M- St. Jude Medical ST. JUDE FRONTIER May 13, 2004
0250 BIVENTRICULAR
CARDIAC PACING
SYSTEM
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P010062/2004M- Euclid Systems EUCLID SYSTEMS June 7, 2004
0260 Corp. ORTHOKERATOLOGY
(OPRIFOCOM A)
CONTACT LENS FOR
OVERNIGHT WEAR
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P030045/2004M- Ev3 Inc. INTRASTENT June 8, 2004
0259 DOUBLESTRUT STENT
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[[Page 58448]]

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: September 23, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-21873 Filed 9-29-04; 8:45 am]

BILLING CODE 4160-01-S