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| Name of Committee | General and Plastic Surgery Devices Panel |
| Date and Time | The meeting was held on the following dates:
Aug 24, 2006 8:00 AM - 5:00 PM
Aug 25, 2006 9:00 AM - 5:00 PM
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| Location | Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
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, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | On August 24, 2006, 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 and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive. Background information for this meeting, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panel (click on “Upcoming CDRH Advisory Panel/Committee Meetings). Material for the August 24 and 25 sessions will be posted on August 23, 2006. |
| Procedure | On August 24, 2006, from 8 a.m. to 5 p.m., and on August 25, 2006, from 9:30 a.m. to 5 p.m., the meeting is 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 on or before August 10, 2006. On August 24, 2006, oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9 a.m., approximately 11:45 a.m. and 12:15 p.m., approximately 1:45 p.m. and 2:15 p.m., and approximately 3:45 p.m. and 4:15 p.m. On August 25, 2006, oral presentations from the public will be scheduled between approximately 11 a.m. and 12 m. Time allotted for each presentation may be limited. 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 August 10, 2006. |
| Closed Committee Information | On August 25, 2006, from 9 a.m. to 9:30 a.m., the meeting will be closed to permit FDA to present to the committee trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) relating to pending issues and applications. |
| | 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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