[Federal Register: June 25, 2004 (Volume 69, Number 122)]
[Notices]
[Page 35654-35655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn04-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004M-0024, 2004M-0147, 2004M-0145, 2004M-0031, 2004M-
0022, 2004M-0012, 2004M-0064, 2004M-0116, 2004M-0084, 2004M-0090,
2004M-0134]
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
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, 2004, through March 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.
[[Page 35655]]
Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From January 1, 2004, through March 31, 2004
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P970020(S40)/ Guidant Corp. ACS MULTI-LINK August 6, 2002
2004M-0024 RX/OTW DUET
CORONARY STENT
SYSTEMS
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P890064(S9)/2004M- Digene Corp. DIGENE HYBRID March 31, 2003
0147 CAPTURE 2 (HC2)
HIGH-RISK HPV
DNA TEST
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P020006/2004M- Enteric Medical ENTERYX April 22, 2003
0145 Technologies, PROCEDURE KIT
Inc.
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P020031/2004M- Microsulis Corp. MICROSULIS September 23,
0031 MICROWAVE 2003
ENDOMETRIAL
ABLATION
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P010059/2004M- Morcher GMBH MORCHER CAPSULAR October 23, 2003
0022 TENSION RING,
TYPES 14, 14A,
and 14C
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P030002/2004M- Eyeonics, Inc. CRYSTALENS MODEL November 14,
0012 AT-45 2003
ACCOMMODATING
POSTERIOR
CHAMBER
INTRAOCULAR
LENS
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P030005/2004M- Guidant Corp. CONTAK RENEWAL January 26, 2004
0064 MODELS H125 and
H120 WITH MODEL
2865 VERSION
1.8 APPLICATION
SOFTWARE
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P030006/2004M- Celsion Corp. PROLIEVE February 19,
0116 THERMODILATION 2004
SYSTEM
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H030004/2004M- Menssana HEARTSBREATH February 24,
0084 Research, Inc. 2004
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H030003/2004M- MicroMed DEBAKEY VAD February 25,
0090 Technology, Inc. CHILD LEFT 2004
VENTRICULAR
ASSIST SYSTEM
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P010018(S5)/2004M- Refractec, Inc. VIEWPOINT CK March 16, 2004
0134 SYSTEM
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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: June 7, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-14439 Filed 6-24-04; 8:45 am]
BILLING CODE 4160-01-S