AGENDA

  CIRCULATORY SYSTEM DEVICES PANEL

 June 22, 2005

Hilton Washington DC North/Gaithersburg, Crystals Ballroom, 620 Perry Parkway, Gaithersburg, MD. 

 

8:00 a.m.                        Call to Order                         William H. Maisel, M.D., M.P.H.

                                                                        Chairperson

8:05– 8:35 a.m.                 *Open Public Session*

                       

 

8:35 – 10:05 a.m.                         Sponsor Presentation: Acorn Cardiovascular

                                    P040049: CorCap CSD

 

10:05 – 10:20 a.m.                        Questions and Answers

 

10:20 – 10:35 a.m.                        Break

 

10:35 – 11:35 a.m.                        FDA Presentation

 

11:35 – 11:55 a.m.                        Questions and Answers

 

12:00 p.m.                        Adjourn – Break for Lunch

 

1:00 p.m.                            Call to Order                                 

 

1:00 – 3:00 p.m.                        Open Committee Discussion                        William H. Maisel, M.D., M.P.H.

 

3:00 – 4:00 p.m.                                  *Open Public Session*

                            FDA Comments

                        Sponsor Comments

                        Recommendations and Vote                        William H. Maisel, M.D., M.P.H.

                       

4:00 p.m.                        Adjourn

 

 

OPEN PUBLIC HEARINGS*

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.