The Food and Drug Administration (FDA) will hold a meeting of its General and Plastic Surgery Devices Panel on on March 25, 2004, from 8 a.m. to 5 p.m. at the Hilton Gaithersburg, 620 Perry Parkway, Salons A, B, C, and D, Gaithersburg , MD 20877

The meeting will be open to the public, and no preregistration is necessary to attend. If you need directions or accommodations, please contact the hotel directly at (301) 977-8900.

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. The material for this meeting will be posted on March 24, 2004 at http://www.fda.gov/cdrh/panelmtg.html.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions should be sent to 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 by March 11, 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 depending on the number of people requesting time to speak.

Those desiring to make formal oral presentations should notify 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,  before March 11, 2004.  Please 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.

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, Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days in advance of the meeting.

Up-to-date information about the meeting can be found on the FDA Advisory Committee page at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=508

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

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