[Federal Register: March 10, 2005 (Volume 70, Number 46)]
[Notices]
[Page 11986-11987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr05-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004M-0538, 2004M-0495, 2004M-0450, 2004M-0467, 2004M-
0471, 2004M-0533, 2004M-0496, 2004M-0497]
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 notification of these actions because
[[Page 11987]]
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 October 1, 2004, through December 31,
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 October 1, 2004, through December 31, 2004
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P020022/2004M- Bayer BAYER VERSANT March 28, 2003
0538 Healthcare, HCV RNA 3.0
LLC ASSAY (bDNA)
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P020021/2004M- Wilson-Cook WIZARD X-CELL August 1, 2003
0495 Medical, PHOTODYNAMIC
Inc./ THERAPY
applicant BALLOON WITH
at approval FIBER OPTIC
was Axcan DIFFUSER
Scandipharm
, Inc.
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P040029/2004M- Szabocsik & JSZ September 29, 2004
0450 Associates ORTHOKERATOLO
GY (OPRIFOCON
A) CONTACT
LENSES FOR
OVERNIGHT
WEAR
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P030032(S1)/2004M- Genzyme HYLAFORM PLUS October 13, 2004
0467 Biosurgery (HYLAN B GEL)
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P030011/2004M- Syncardia SYNCARDIA October 15, 2004
0471 Systems, TEMPORARY
Inc. CARDO WEST
TOTAL
ARTIFICAL
HEART (TAH-t)
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P040002/2004M- Endologix, ENDOLOGIX October 29, 2004
0533 Inc. POWERLINK
SYSTEM
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P040022/2004M- Medtronic, EVS VASCULAR November 3, 2004
0496 Inc./ CLOSURE
applicant SYSTEM
at approval
was
AngioLink
Corp.
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P030031/2004M- Biosense BIOSENSE November 5, 2004
0497 Webster, WEBSTER
Inc. NAVISTAR/
CELSIUS
THERMO-COOL
DIAGNOSTIC/
ABLATION
DEFLECTABLE
TIP CATHETERS
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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: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4763 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S