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Center | Date | Time | Location |
---|---|---|---|
CDRH | June
8, 2004 |
8 a.m. - 5 p.m. | Hilton Washington
D.C. North |
Agenda:
The committee will discuss, make recommendations, and vote on a premarket approval
application for a left ventricular assist system. The system is intended for
use as a short or long term bridge to transplantation in cardiac transplant
patients, and in patients with relative contraindication to transplantation
who are expected to become transplant candidates with mechanical circulatory
support, at risk of imminent death from nonreversible left ventricular failure.
The device is indicated for use both inside and outside of the hospital.
Background material and meeting information will become available no later than one business 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 25, 2004. On June 8, 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 May 25, 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.