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| Name of Committee | General and Plastic Surgery Devices Panel |
| Date and Time | The meeting was held on the following dates:
May 12, 04 8:00 AM - 5:00 PM
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| Location | Gaithersburg Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Avenue
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 or access the Internet address of http://www.fda.gov/cdrh/panelmtg.html 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 in situ polymerizable sealant material intended to be used to seal air leaks following pulmonary surgery. 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 May 11, 2004. |
| Closed Committee Information | On May 12, 2004, from 8 a.m. to 8:30 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. |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
