[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Notices]
[Pages 50995-50996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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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    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 September 11, 2000, 10 
a.m. to 6 p.m.
    Location: Marriott Washingtonian Center, Salons C and D, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Megan Moynahan, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8517, ext. 171, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the

[[Page 50996]]

Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an intravascular radiation 
device used in the treatment of instent restenosis.
    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 September 1, 
2000. Oral presentations from the public will be scheduled between 
approximately 10 a.m. and 10:30 a.m. on September 11, 2000. Near the 
end of committee deliberations, a 30-minute open public session will be 
conducted for interested persons to address issues specific to the 
submission before the committee. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 1, 2000, 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: August 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-21246 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F