[Federal Register Volume 63, Number 192 (Monday, October 5, 1998)]
[Notices]
[Page 53445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26571]
[[Page 53445]]
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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 October 27, 1998, 8 a.m.
to 5 p.m.
Location: Hilton Hotel, Salons C, D, and E, 620 Perry Pkwy.,
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, make recommendations, and vote
on a premarket approval application for a transmyocardial
revascularization device.
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 October 16,
1998. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. 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 October 16, 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: September 28, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-26571 Filed 10-2-98; 8:45 am]
BILLING CODE 4160-01-F
