[Federal Register: November 6, 2003 (Volume 68, Number 215)]
[Notices]
[Page 62812-62813]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no03-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003M-0287, 2003M-0271, 2003M-0272, 2003M-0262, 2003M-
0175, 2003M-0240, 2003M-0189, 2003M-0241, 2003M-0332, 2003M-0337,
2003M-0174, 2003M-0173, 2003M-0190, 2003M-0343, 2003M-0242, 2003M-0333,
2003M-0339, 2003M-0320, 2003M-0352, 2003M-0157]
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 January 30, 1998 (63 FR 4571), FDA 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 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 April 1, 2003, through June 30, 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 April 1, 2003, through June 30, 2003
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PMA No./Docket Approval
No. Applicant Trade Name Date
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P010052/2003M- Diagnostic Immulite/Immulite 2000 July 22,
0287 Products Corp. Anti-HBS 2002
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P010051/2003M- Diagnostic Immulite/Immulite 2000 July 24,
0271 Products Corp. Anti-HBC 2002
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P010053/2003M- Diagnostic Immulite/Immulite 2000 July 26,
0272 Products Corp. Anti-HBC IGM 2002
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P010050/2003M- Diagnostic Immulite/Immulite 2000 July 26,
0262 Products Corp. HBSAF 2002
and Immulite HBSAF
Confirmatory Kit
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P020014/2003M- Conceptus, Inc. Essure System November 4,
0175 2002
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P990069/2003M- EpMed Systems, Alert System (Alert November 27,
0240 Inc. Catheter, Alert 2002
Interface Cable, and
Alert Companion With
Software Version
1.08)
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P010055/2003M- Prostalund Prostalund Coretherm December 23,
0189 Operations AB System Microwave 2002
Thermotherapy for BPH
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P020028/2003M- Philips Medical Series 50 XMO (Model January 3,
0241 System M1350C) Fetal/ 2003
Maternal Monitor
System With Integrated
Fetal Oxygen
Saturation Monitoring
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[[Page 62813]]
P990027(S004)/ Bausch & Lomb Technolas 217A Excimer February 25,
2003M-0174 Surgical, Inc. Laser System 2003
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P990086(S003)/ Health Tronics Healthtronics Ossatron March 14,
2003M-0173 Surgical 2003
Services, Inc.
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P980035(S013)/ Medtronic, Inc. Medtronic AT500 DDDRP March 27,
2003M-0190 Pacing System 2003
(Model A1501) and
Model 9968 Software
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H020007/2003M- Medtronic Medtronic Activa April 15,
0157 Neurological Dystonia Therapy 2003
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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: October 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27882 Filed 11-5-03; 8:45 am]
BILLING CODE 4160-01-S