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| Name of Committee | General and Plastic Surgery Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 25, 04 8:00 AM - 5:00 PM
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| Location | Hilton Washington, DC North/Gaithersburg
620 Perry Parkway, Salons A, B, C, and D
Gaithersburg
, MD |
| Contact Information | David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access this Internet page for up-to-date information on this meeting. |
| Agenda | The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients. Background information for this PMA, 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. The material for this meeting will be posted on March 24, 2004. |
| 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 March 15, 2004. On March 25, 2004, oral presentations from the public will be scheduled for approximately one hour at the beginning of committee deliberations and for approximately one hour near the end of the deliberations. Time allotted for oral public presentations may be limited. Those desiring to make formal oral presentations should notify the contact person before March 15, 2004 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 |
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| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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