[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Notices]
[Page 37926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18524]
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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: 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 August 6, 1997, 10 a.m.
to 5 p.m., and August 7, 1997, 9:30 a.m. to 2 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, 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: On August 6, 1997, the committee will hear a presentation
of the basic concepts of FDA's Product Development Protocol Process.
The committee will discuss issues relating to a premarket approval
application (PMA) for an implanted neuromuscular stimulator for the
management of urinary urge incontinence. On August 7, 1997, the
committee will discuss and advise FDA on the classification of External
Penile Rigidity Devices and an update of the Triage list of
gastroenterology and urology devices will be presented and discussed.
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 30, 1997.
Oral presentations from the public will be scheduled between
approximately 10 a.m. and 11 a.m. on August 6, 1997, and between
approximately 9 a.m. and 10 a.m. on August 7, 1997. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 30, 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: July 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-18524 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F
