[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Pages 32618-32619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15633]
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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 July 28, 1997, 9:30 a.m.
to 6 p.m., and July 29, 1997, 8:30 a.m. to 3:30 p.m.
Location: Holiday Inn--Gaithersburg, Walker/Whetstone Salons, Two
Montgomery Village Ave., 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
[[Page 32619]]
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 July 28, 1997, the committee will discuss a premarket
approval application (PMA) for a transmyocardial revascularization
device. On July 29, 1997, the committee will discuss a PMA for a laser
sheath for pacing lead extraction.
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 July 18, 1997.
Oral presentations from the public will be scheduled between
approximately 9:30 a.m. to 10:30 a.m. on July 28, 1997, and between
approximately 8:30 a.m. to 9:30 a.m. on July 29, 1997. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before July 18,
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: June 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-15633 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
