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Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Agenda:
On September 8, 2005, the committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also hear an update on the status of recent devices brought before the committee. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for a hip joint metal/metal semi constrained resurfacing hybrid prosthesis (cemented femoral component). The device is intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes.

On September 9, 2005, the committee will discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain.

Background material and meeting information will become available no later than one business day before eachmeeting day. (Simply scroll down to the appropriate committee heading).

Closed Committee Deliberations:
On September 8, 2005, from 8:00 a.m. - 8:30 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)) relating to pending issues and applications.

Procedure:
On September 8, 2005, from 8:30 a.m. to 6 p.m., the meeting will be 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 August 29, 2005. On September 8, 2005, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of the committee deliberations and for approximately 30 minutes near the end of the deliberations. On September 9, 2005, oral presentations from the public will be scheduled from approximately 8:30 a.m. to 9:30 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 29, 2005, 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.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Shirley Meeks at 240-276-0450, ext 105, at least 7 days in advance of the meeting.

Contact Person:
Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512521.