AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
January
13, 2005
Hilton Gaithersburg Washington D.C./North, Salons A, B & C, 620 Perry Parkway, Gaithersburg, MD.
9:00 – 5:00 PMA Discussion and Recommendations
9:00 a.m. Call
to Order William
H. Maisel, M.D., M.P.H.
Acting Chairperson
9:05 – 9:20 a.m. FDA Presentation -
Critical Path Initiative
Dr. Binita
Ashar; Acting Clinical Director; CDRH
9:20 – 9:35 a.m. FDA
Presentation – Panel Update
Megan
Moynahan; Branch Chief; Pacing, Defibrillator Leads Branch; CDRH
9:35 – 10:05 a.m. *Open
Public Session*
10:05 – 11:05 a.m. Sponsor
Presentation: W.L. Gore
& Associates, Inc.
P040043: Gore TAG
Thoracic Endoprosthesis
11:05 – 11:20 a.m. Questions
and Answers
11:20 – 11:30 a.m. Break
11:30 – 12:30 p.m. FDA Presentation
12:30 – 12:45 p.m. Questions
and Answers
12:45 p.m. Adjourn – Break
for Lunch
1:45 p.m. Call to Order
1:45 – 3:45
p.m. Open Committee
Discussion William
H. Maisel, M.D.
3:45 – 4:00
p.m. Break
4:00 – 5:00
p.m. *Open Public Session*
FDA Comments
Sponsor
Comments
Recommendations
& Vote William H. Maisel, M.D.
5:00 p.m. Adjourn
Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Ms. Wood will present the speakers who have
requested time for presentation to the Panel.
After the scheduled speakers have spoken, the Chair may ask them to
remain if the committee wishes to question them further. Dr. Maisel will recognize unscheduled
speakers as time allows.
Note: Only the Chair and members of the Panel may
question speakers during the open public hearing.