[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Notices]
[Page 32014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15556]
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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 June 29 and 30, 1998, 8
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, 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: On June 29, 1998, the committee will discuss, make
recommendations, and vote on a premarket approval application for an
external compression device used in cardiopulmonary resuscitation. On
June 30, 1998, the committee will discuss and make recommendations on
permanent cardiovascular implants such as heart valves and vascular
grafts.
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 June 18, 1998.
Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. on June 29 and 30, 1998. Near the
end of committee deliberations on both days, a 30-minute open public
session will be conducted to address issues specific to the submission
or topic before the committee. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before June 18, 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: June 4, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-15556 Filed 6-10-98; 8:45 am]
BILLING CODE 4160-01-F
