Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

[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 ``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