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| Name of Committee | Neurological Devices Panel |
| Date and Time | The meeting was held on the following dates:
Nov 30, 04 8:00 AM - 5:00 PM
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| Location | Hilton Washington DC North/Gaithersburg, Salons A, B, and C
620 Perry Pkwy.
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, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512513. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | The committee will discuss, make recommendations, and vote on premarket approval application for a device intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. Background information for the topic, 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/panelmtg.html |
| Procedure | On November 30, 2004, from 8:30 a.m. to 5 p.m., the meeting will be open to the public. nterested 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 November 9, 2004. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 9, 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. |
| Closed Committee Information | On November 30, 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. |
| Related Documents | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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