[Federal Register: October 5, 1998 (Volume 63, Number 192)]
[Notices]               
[Page 53445]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc98-85]


[[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