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| Name of Committee | Orthopaedic and Rehabilitation Devices Panel |
| Date and Time | The meeting was held on the following dates:
Jan 10, 02 9:30 AM - 5:00 PM
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| Location | Gaithersburg Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg
, MD |
| Contact Information | 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 spinal fusion cage with a growth factor soaked in a collagen sponge intended for use to treat lumbar degenerative disc disease. Background information, including the agenda and questions for the committee, will be available to the public on January 9, 2002, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. |
| Procedure | On January 10, 2002, from 9:30 a.m. to 1 p.m., and from 2 p.m. to 5 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 January 4, 2002. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m. on January 10, 2002. Near the end of the committee deliberations for the PMA, 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 January 4, 2002, 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 Information | On January 10, 2002, from 1 p.m. to 2 p.m., the meeting will be closed to the public to permit the committee to discuss and review trade secret and/or confidential commercial information presented by a sponsor (5 U.S.C. 552b(c)(4)). |
| Conduct | FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings. |
| Related Documents | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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