April 10, 2003


Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Parkway, Gaithersburg, MD


9:00 – 5:00     PMA Discussion, Recommendations, and Voting


9:00 a.m.                        Call to Order                         Warren K. Laskey, M.D., Acting Chairperson


9:05 – 9:35 a.m.*                        Open Public Session*


9:35 - 9:45 a.m.                        Survey


9:45 – 11:00 a.m.                        Sponsor Presentation:  Cook Incorporated

                        P020018, Cook Zenithฎ AAA Endovascular Graft


11:00 – 11:15 a.m.                        Questions and Answers


11:15 – 12:15 p.m.                        FDA Presentation


12:15 – 12:30 p.m.                        Questions and Answers


12:30 p.m.       Adjourn – Break for Lunch


1:30 – 2:30 p.m.                            Call to Order                                 


2:30 – 3:30 p.m.                            Open Committee Discussion                                      Warren K. Laskey, M.D.


3:30 – 3:45 p.m.                        Break


3:45 – 5:00 p.m.                                  *Open Public Session*

                            FDA Comments

                        Sponsor Comments

                        Recommendations & Vote                               Warren K. Laskey, 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. Laskey will recognize unscheduled speakers as time allows.

Note: Only the Chair and members of the Panel may question speakers during the open public hearing.