[Federal Register Volume 63, Number 67 (Wednesday, April 8, 1998)]
[Notices]
[Page 17186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9187]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: Gastroenterology and Urology 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 April 30, 1998, 9:30
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Mary J. Cornelius, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 118, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12523. 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 lithotripter used to fragment
biliary stones.
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 April 20,
1998. Oral presentations from the public will be scheduled between 9:30
a.m. and 10 a.m. Near the end of the committee deliberations, a 30-
minute open public session will be conducted for interested persons to
address issues specific to the submission before the committee. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before April
20, 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: April 1, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-9187 Filed 4-7-98; 8:45 am]
BILLING CODE 4160-01-F
