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| Center | Date | Time | Location |
|---|---|---|---|
| CDRH | April 21, 2004 | 9 a.m. - 5 p.m. | Gaithersburg Marriott |
Agenda:
The committee will discuss, make recommendations, and vote on a premarket approval
application for a carotid stent indicated for use in the treatment of carotid
artery disease in high-risk patients.
Background material and meeting information
will become available no later than the day before the meeting (Simply select
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 April 12, 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 April 12, 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 AnnMarie Williams, Conference Management Staff, at 301-594-1283,
ext. 113, at least 7 days in advance of the meeting.
Contact Person:
Geretta Wood, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320,
ext. 143, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512625. Please call the Information Line
for up-to-date information on this meeting.
[ Full FR Notice ]