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.