[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64268-64269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30936]
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DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 64269]]
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 7, 1998, 8 a.m.
to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: John E. Stuhlmuller, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8243, ext. 157, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12625. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss and make recommendations on
clinical trial requirements for future approval of coronary stents. An
outline of the types of issues to be discussed by the committee can be
found on the FDA website at ``http://www.fda.gov/cdrh/upadvmtg.html''.
Single copies of this outline are also available to the public by
contacting the Division of Small Manufacturers Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 1-800-638-2041 or 301-443-6597.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by November 30,
1998. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m., on December 7, 1998. Near the end
of committee deliberations, a 30-minute open public hearing will be
conducted for interested persons to address issues specific to the
topics before the committee. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before November 30, 1998, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 12, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-30936 Filed 11-18-98; 8:45 am]
BILLING CODE 4160-01-F
