[Federal Register Volume 65, Number 124 (Tuesday, June 27, 2000)]
[Notices]
[Page 39624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation Devices Panel of 
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 20, 2000, 9:30 a.m. 
to 5 p.m.
    Location: Holiday Inn, Walker and Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Hany W. Demian, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12521. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on premarket approval application (PMA) for a shock wave lithotriptor 
used for the treatment of heel pain and a PMA for a ceramic on ceramic 
total hip arthroplasty.
    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 13, 2000. 
Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 10 a.m. on July 20, 2000. Near the end of 
the committee deliberations for both PMA's, 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 July 13, 2000, 
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 20, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16195 Filed 6-26-00; 8:45 am]
BILLING CODE 4160-01-F