March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting Annoucement
|Name of Committee||Orthopaedic and Rehabilitation Devices Panel|
|Date and Time||The meeting was held on the following dates:|
Mar 31, 09 8:00 AM - 5:00 PM
|Location||Hilton Washington DC North/Gaithersburg, Salons A, B, and C|
620 Perry Pkwy.
Gaithersburg , MD
|Contact Information||Ronald P. Jean, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 240-276-3676 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 Ronald.Jean@fda.hhs.gov)|
|Agenda||The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for OP-1 Putty, sponsored by Stryker Biotech. This combination product is indicated for posterolateral spinal fusion procedures in skeletally mature patients with lumbar spondylolisthesis who have failed at least 6 months of conservative nonsurgical treatment.|
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.
|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 on or before March 24, 2009. Oral presentations from the public will be scheduled for 30 minutes at the beginning of the committee deliberations and for 30 minutes near the end of the deliberations. Those desiring to make formal oral presentations should notify the contact person 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 on or before March 20, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 23, 2009.|
|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. Information about procedures on public conduct during advisory committee meetings: Public Conduct During FDA Advisory Committee Meetings.|