[Federal Register Volume 62, Number 161 (Wednesday, August 20, 1997)]
[Notices]
[Page 44283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 regulatory issues.
Date and Time: The meeting will be held on September 15, 1997, 9:30
a.m. to 6 p.m., and September 16, 1997, 8:30 a.m. to 3 p.m.
Location: Gaithersburg Hilton, Salons A, B, and C of the Ballroom,
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: On September 15, 1997, the committee will hear a
presentation of the basic concepts of FDA's Product Development
Process. The committee will discuss and make recommendations on two
premarket approval (PMA) applications for prosthetic heart valves. On
September 16, 1997, the committee will discuss and make recommendations
on a PMA for a prosthetic heart valve.
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 5,
1997. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 10:30 a.m. on September 15, 1997, and
between approximately 8:30 a.m. and 9:30 a.m. on September 16, 1997.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
September 5, 1997, 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, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-22089 Filed 8-19-97; 8:45 am]
BILLING CODE 4160-01-F
