[Federal Register: April 8, 1998 (Volume 63, Number 67)]
[Notices]               
[Page 17186]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap98-93]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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