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Center | Date | Time | Location |
---|---|---|---|
CDRH | June 22, 2005 June 23, 2005 |
8:00 a.m. - 4:30
p.m. 8:00 a.m. - 4:30 p.m. |
Hilton Washington
DC North |
Agenda:
On June 22, 2005, the committee will discuss, make recommendations, and vote
on a premarket approval application for a cardiac device intended to treat patients
with heart failure.
On June 23, 2005, the committee will discuss, make recommendations, and vote on a humanitarian device exemption for an artificial heart.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
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 June 8, 2005. 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 June 8, 2005, 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 240-276-0450,
ext. 105, 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.
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this
meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512625.