[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Page 8666-8667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 17 and 18, 2004, 
from 9 a.m. to 5 p.m.
    Location: Hilton Washington D.C. North/Gaithersburg, Salons A, B, 
and C, 620 Perry Pkwy., Gaithersburg, MD.
    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.
    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 replaces 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

[[Page 8667]]

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 information 
for the day's topics, including the agenda and questions for the 
committee, will be available to the public 1 business day before the 
meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. 

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 
    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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 19, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-4034 Filed 2-24-04; 8:45 am]