[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Page 62777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30914]


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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). At least one 
portion of the meeting will be closed 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 regulatory issues.
    Date and Time: The meeting will be held on December 11, 1997, 9 
a.m. to 8 p.m., and December 12, 1997, 8 a.m. to 2 p.m.
    Location: Holiday Inn, Versailles Ballrooms III and IV, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Jodi H. Nashman, 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: On December 11, 1997, the committee will discuss, make 
recommendations, and vote on one premarket approval application (PMA) 
for a spinal intervertebral fusion device. Additionally, there will be 
a general discussion of the minimum acceptable length of patient 
followup for marketing approval of spinal implant devices. On December 
12, 1997, the committee will discuss, make recommendations, and vote on 
a PMA for an anti-adhesion barrier gel.
    Procedure: On December 11, 1997, from 9 a.m. to 8 p.m., and on 
December 12, 1997, from 9 a.m. to 2 p.m., the meeting is open to the 
public. 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 December 3, 1997. Oral 
presentations from the public regarding spinal intervertebral fusion 
systems and devices will be scheduled between approximately 9 a.m. and 
10 a.m., on December 11, 1997. Oral presentations from the public 
regarding anti-adhesion barrier gels will be scheduled between 9 a.m. 
and 10 a.m., on December 12, 1997. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before December 3, 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.
    Closed Committee Deliberations: On December 12, 1997, from 8 a.m. 
to 9 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) 
regarding present and future FDA issues.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 18, 1997.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 97-30914 Filed 11-24-97; 8:45 am]
BILLING CODE 4160-01-F