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Center | Date | Time | Location |
---|---|---|---|
CDRH | June 3, 2004 | 8:30 a.m. - 4:30 p.m. | Holiday Inn |
Agenda:
The committee will discuss, make recommendations, and vote on a premarket approval
application for a system that ablates uterine fibroids using focused ultrasound
under the guidance of magnetic resonance.
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 May 26, 2004. Oral presentations from the public will be scheduled
between approximately 8:45 a.m. and 9:15 a.m. and between approximately 3 p.m.
and 3:30 p.m. on June 3, 2004. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the contact person
before May 26, 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:
Joyce M. Whang, Center for Devices and Radiological Health (HFZ-470), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512524. Please call the Information Line
for up-to-date information on this meeting.