CIRCULATORY SYSTEM DEVICES PANEL
January 13, 2005
Hilton Gaithersburg Washington D.C./North, Salons A, B & C, 620 Perry Parkway, Gaithersburg, MD.
9:00 a.m. Call to Order William H. Maisel, M.D., M.P.H.
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*
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.