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FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| CDRH | March 17, 2004 March 18, 2004 |
9 a.m. - 5 p.m. 9 a.m. - 5 p.m. |
Hilton Washington
D.C. North |
Agenda:
On March 17, 2004, the committee will discuss, make recommendations, and vote
on a premarket approval application for a Total Artificial Heart indicated for
bridge to transplant usage in cardiac transplant-eligible candidates at risk
of imminent death from non-reversible biventricular failure and replacing the
patient's native ventricles and valves. The device is intended for use inside
the hospital.
On March 18, 2004, FDA will present to the committee the history, current medical
practice, and regulatory background regarding Aortic Anastomotic Devices. The
committee will discuss and make recommendations regarding the type of data and
study required to effectively evaluate performance of Aortic Anastomotic Devices
for marketing, recognizing the significant public health impact on cardiac disease
they represent.
Background material and meeting information
will become available no later than the day before each meeting (Simply select
the appropriate committee link). Material for the March 17, 2004, session will
be posted on March 16, 2004; material for the March 18, 2004, session will be
posted on March 17, 2004.
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 March 8, 2004. On March 17, 2004, oral presentations from
the public will be scheduled for approximately 30 minutes at both the beginning
and near the end of committee deliberations. On March 18, 2004, oral presentations
from the public will be scheduled from approximately 10 a.m. to 12:30 p.m. 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 March 8,2004, 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 ]