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| Name of Committee | Orthopaedic and Rehabilitation Devices Panel |
| Date and Time | The meeting was held on the following dates:
Nov 20, 2002 9:30 AM - 5:00 PM
Nov 21, 2002 9:30 AM - 5:00 PM
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| Location | 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. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512521. Please call the Information Line or access this Internet page for up-to-date information on this meeting. (E-mail contact HWD@cdrh.fda.gov) |
| Agenda | On November 20, 2002, the committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a stair-climbing wheelchair. On November 21, 2002, the committee will discuss, make recommendations, and vote on a PMA for growth factors soaked in a collagen sponge used to treat tibial fractures. In addition, on November 21, 2002, the committee will have a general discussion on preclinical and clinical data for spinal devices. Background information for each day’s topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the November 20, 2002, session will be posted on November 19, 2002; material for the November 21, 2002, session will be posted on November 20, 2002. |
| 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 November 8, 2002. On each day, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of each PMA topic and for approximately 30 minutes near the end of the committee deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 8, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| 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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