[Federal Register: December 15, 2004 (Volume 69, Number 240)]
[Notices]
[Page 75073-75075]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de04-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003M-0172, 2004M-0309, 2004M-0433, 2004M-0341, 2004M-
0356, 2004M-0403, 2004M-0310, 2004M-0312, 2004M-0313, 2004M-0342,
2004M-0323, 2004M-0345, 2004M-0350, 2004M-0387, 2004M-0415, 2004M-0388,
and 2004M-0430]
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
[[Page 75074]]
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 July 1, 2004, through September 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 July 1, 2004, through September 30, 2004
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P020026/2003M- Cordis Corp. CYPHER SIROLIMUS- April 24,
0172 ELUTING CORONARY 2003
STENT ON THE RAPTOR
OVER-THE-WIRE
DELIVERY SYSTEM OR
RAPTORRAIL RAPID
EXCHANGE DELIVERY
SYSTEM
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P020023/2004M- Q-Med RESTYLANE INJECTABLE December 12,
0309 Scandinavia, GEL 2003
Inc.
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P030044/2004M- DakoCytomation DAKOCYTOMATION EGFR February 12,
0433 California, PHARMDX 2004
Inc.
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P030024/2004M- Ortho-Clinical VITROS March 4, 2004
0341 Diagnostics, IMMUNODIAGNOSTIC
Inc. PRODUCTS ANTI-HBC
REAGENT PACK AND
CALIBRATOR
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P030026/2004M- Ortho-Clinical VITROS March 4, 2004
0356 Diagnostics, IMMUNODIAGOSTIC
Inc. PRODUCTS ANTI-HBC
IGM REAGENT PACK AND
CALIBRATOR
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P030025/2004M- Boston TAXUS EXPRESS2 March 4, 2004
0403 Scientific PACLITAXEL-ELUTING
Corp. CORONARY STENT
SYSTEM (MONORAIL AND
OVER-THE-WIRE)
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P020030/2004M- Ela Medical, STELID II/STELIX/ June 17, 2004
0310 Inc. STELIX II
ENDOCARDIAL PACING
LEAD
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P970043 (S015)/ Alcon LADARVISION 4000 June 29, 2004
2004M-0312 Laboratories, EXCIMER LASER SYSTEM
Inc.
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P030054/2004M- St. Jude ST. JUDE MEDICAL EPIC June 30, 2004
0313 Medical, Inc. HF SYSTEM
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P040008/2004M- bioMerieux, Inc. VIDAS TPSA ASSAY July 8, 2004
0342
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P030012/2004M- R2 Technology, IMAGECHECKER CT CAD July 8, 2004
0323 Inc. SOFTWARE SYSTEM
(MODEL LN-1000)
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P010061/2004M- Photo Cure, ASA CURELIGHT BROADBAND July 28, 2004
0345 (MODEL CURELIGHT 01)
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P030050/2004M- Dermik SCULPTRA August 3,
0350 Laboratories 2004
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P030010/2004M- Siemens Medical SIEMENS MAMMOMAT August 20,
0387 Solutions USA, NOVATIONDR FULL 2004
Inc. FIELD DIGITAL
MAMMOGRAPHY SYSTEM
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H030009/2004M- Synthes (USA) VERTICAL EXPANDABLE August 24,
0415 PROSTHETIC TITANIUM 2004
RIB (VEPTR)
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P040012/2004M- Guidant Corp. ACULINK CAROTID STENT August 30,
0388 SYSTEM & RX ACCULINK 2004
CAROTID STENT SYSTEM
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P010012 (S026)/ Guidant Corp. CONTAK CD (MODEL September 14,
2004M-0430 1823), CONTAK CD 2 2004
(MODELS H115 &
H119), RENEWAL
(MODEL H135),
RENEWAL 3 (MODELS
H170, H175, H177, &
H179)
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[[Page 75075]]
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 3, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-27387 Filed 12-14-04; 8:45 am]
BILLING CODE 4160-01-S