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Center | Date | Time | Location |
---|---|---|---|
CDRH | February 23, 2004 | 9:30 a.m. - 5 p.m. | Hilton Washington,
DC North/Gaithersburg |
Agenda:
The committee will discuss and make recommendations on a premarket notification
submission for a thrombectomy device.
Background material and meeting information will become available no later than the day before the meeting (Simply scroll down to the appropriate committee link).
Procedure:
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 February 9, 2004. Oral presentations from the public will
be scheduled between approximately 9:45 a.m. and 10:45 a.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before February 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. Persons attending FDA's advisory
committee meetings are advised that the agency is not responsible for providing
access to electrical outlets.
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.
Contact Person:
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.