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| Name of Committee | Neurological Devices Panel |
| Date and Time | The meeting was held on the following dates:
Aug 5, 03 10:00 AM - 5:30 PM
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| Location | Holiday Inn, Walker/Whetstone Ballroom
Two Montgomery Village Ave.
Gaithersburg
, MD |
| Contact Information | Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512513. Please call the Information Line or access this Internet page for up-to-date information on this meeting. (E-mail contact JLS@cdrh.fda.gov) |
| Agenda | The committee will discuss, make recommendations, and vote on a premarket approval application for a neurological embolization device. Background information for the topic, 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. Material will be posted on August 4, 2003. |
| Procedure | From 10:30 a.m. to 5:30 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 by July 22, 2003. Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:15 a.m. and approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 22, 2003, 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. |
| Closed Committee Information | From 10 a.m. to 10:30 a.m., the meeting will be closed to the public to permit discussion of trade secret and/or confidential information regarding neurological device issues (5 U.S.C. 552b(c)(4)). |
| | 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). |
