[Federal Register: July 15, 2005 (Volume 70, Number 135)]
[Notices]
[Page 41041-41043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy05-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M-0024, 2005M-0025, 2005M-0026, 2005M-0092, 2005M-
0087, 2005M-0055, 2005M-0089, 2005M-0027, 2005M-0109, 2005M-0028,
2005M-0088, 2005M-0110, 2005M-0132]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 41042]]
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 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 January 1, 2005, through March 31,
2005. 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 January 1, 2005, through March 31, 2005
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PMA No./Docket No. Applicant TRADE NAME Approval Date
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P010058/2005M-0024 Medilink OSTEOSPACE March 15,
2004
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P030029/2005M-0025 Bayer ADVIA CENTAUR ANTI May 14, 2005
HealthCare, HBs READYPACK
LLC REAGENTS & ADVIA
CENTAUR ANTI HBs
READYPACK
CALIBRATORS
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P030028/2005M-0026 Ophtec USA, ARTISAN (MODEL 206 & September 10,
Inc.; Ophtec 204) PHAKIC 2004
BV INTRAOCULAR LENS
(PIOL) VERISYSE
(VRSM5US & VRMA6US)
PHAKIC INTRAOCULAR
LENS
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P040006/2005M-0092 DePuy Spine, CHARITE ARTIFICIAL October 26,
Inc. DISC 2004
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P030007/2005M-0087 Eastman Kodak KODAK MAMMAGRAPHY November 23,
Co. CAD ENGINE 2004
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P930016 (S17)/ VISX, Inc. STAR S4 EXCIMER December 14,
2005M-0055 LASER SYSTEM WITH 2004
VARIABLE SPOT
SCANNING (VSS) &
WAVESCAN WAVEFRONT
SYSTEM
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P030030/2005M-0089 Genyx Medical URYX URETHRAL December 16,
BULKING AGENT 2004
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P030022/2005M-0027 Smith & Nephew, REFLECTION CERAMIC December 17,
Inc. ACETABULAR SYSTEM 2004
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P040004/2005M-0109 Bayer ADVIA CENTAUR HBC December 22,
Healthcare LLC TOTAL READY PAK 2004
REAGENTS & ADVIA
CENTAUR HBC TOTAL
QUALITY CONTROL
MATERIALS
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P030034/2005M-0028 Orthofix, Inc. CERVICAL-STIM MODEL December 23,
505L CERVICAL 2004
FUSION SYSTEM
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P040014/2005M-0088 Irvine IBI THERAPY CARDIAC January 14,
Biomedical, ABLATION SYSTEM 2005
Inc.
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[[Page 41043]]
P040017/2005M-0110 Bayer ADVIA CENTAUR ANTI- March 7, 2005
Healthcare, HAV TOTAL ASSAY &
LLC ADVIA CENTAUR TOTAL
QUALITY CONTROL
MATERIALS
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H030005/2005M-0132 CoAxia, Inc. COAXIA NEUROFLO March 30,
CATHETER 2005
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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: July 6, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-13901 Filed 7-14-05; 8:45 am]
BILLING CODE 4160-01-S