[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Notices]
[Page 61447-61448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-64]
[[Page 61447]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003M-0045, 2003M-0122, 2003M-0010, 2003M-0040, 2003M-
0086, 2003M-0116, 2003M-0049, 2003M-0070, 2003M-0011, 2003M-0046,
2003M-0114, 2003M-0115]
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
revised 21 CFR 814.44(d) and 814.45(d) (63 FR 4571) to discontinue
individual publication of PMA approvals and denials in the Federal
Register. Instead, the agency now posts this information to FDA's home
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov on the Internet. 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, 2003, through March 31,
2003. 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 January 1, 2003, through March 31, 2003
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PMA No./
Docket No. Applicant Trade Name Approval Date
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P990071/ Biosense STOCKERT 70 RF GENERATOR May 31, 2000
03M-0045 Webster, FOR CARDIAC ABLATION
Inc.
P980048/ Sulzer Spine- BAK/CERVICAL (BAK/C) April 20, 2001
03M-0122 Tech INTERBODY FUSION SYSTEM
P990065/ Sirtex SIR-SPHERES March 5, 2002
03M-0010 Medical,
Inc.
P010002/ United INDERMIL TISSUE ADHESIVE May 22, 2002
03M-0040 States
Surgical
Corp.
P010041/ Edwards CARPENTIER-EDWARDS June 24, 2002
03M-0086 Lifescience S.A.V. BIOPROSTHESIS,
s, LLC MODEL 2650 (AORTIC)
P020009/ Boston EXPRESS/EXPRESS 2 September 11, 2002
03M-0116 Scientific, MONOTRAIL AND OVER THE
Scimed, WIRE CORONARY STENT
Inc. SYSTEMS
P010068/ Biosense NAVISTAR DS/CELSIUS DS September 27, 2002
03M-0049 Webster, DIAGNOSTIC ABLATION
Inc. CATHETERS, STOCKERT 70
GENERATOR, AND CATHETER
INTERFACE CABLES
P020011/ Gen-Probe, VERSANT HCV RNA November 7, 2002
03M-0070 Inc. QUALITATIVE ASSAY
P020008/ Karl Storz KARL STORZ December 12, 2002
03M-0011 Endoscopy- AUTOFLUORESCENCE SYSTEM
America
P020027/ Dade DIMENSION FPSA FLEX January 24, 2003
03M-0046 Behring, REAGENT CARTRIDGE AND
Inc. DIMENSION T/F PSA
CALIBRATOR FOR
DIMENSION RXL AND XPAND
SYSTEMS
P800022(S5 Inamed Corp. COSMODERM 1 & COSMOPLAST March 11, 2003
0)/03M- HUMAN-BASED COLLAGEN
0114
P010065/ E Med Future NEEDLE ZAP March 14, 2003
03M-0115
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[[Page 61448]]
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 6, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27119 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S