AGENDA

CIRCULATORY SYSTEM DEVICES PANEL

September 10, 2001

Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD

9:00 – 1:00 First PMA Discussion, Recommendations, and Voting

9:00 a.m. Call to Order Cynthia Tracy, M.D., Chairperson

9:05 – 9:15 a.m.* Open Public Hearing*

9:15 – 10:15 a.m. Sponsor Presentation: AGA Medical

P000039, Amplatzer® Septal Occluder and Delivery System

Franck Gougeon, Executive Vice President, AGA Medical Corporation

Ziyad Hijazi, MD, University of Chicago Children’s Hospital, Chicago

John Cheatham, MD, The Nemours Cardiac Center, Orlando

John Moore, MD, St. Christopher’s Children’s Hospital, Philadelphia

10:15 – 10:30 a.m. FDA Presentation

Donna Buckley, lead reviewer

John E. Stuhlmuller, MD, clinical reviewer

10:30 – 12:45 p.m. Open Committee Discussion, Recommendations, Cynthia Tracy, M.D.
and Voting

11:00 – 11:15 a.m. Break

12:45 – 1:00 p.m.* Open Public Hearing*

1:00 p.m. Adjourn – Break for Lunch

2:00 – 6:00 p.m. Second PMA Discussion, Recommendations, and Voting

2:00 p.m. Call to Order Cynthia Tracy, M.D.

2:05 – 2:15 p.m.* Open Public Hearing*

2:15 – 3:15 p.m. Sponsor Presentation: NMT Medical, Inc.

P000049, CardioSEAL Septal Occlusion System with Qwikload

John Ahern, President, CEO and Chairman, NMT Medical, Inc

Carol Ryan, Vice President, Research and Development, NMT Medical

John E. Mayer, MD, Boston Children’s Hospital / Harvard Medical School

Peter C. Laussen, MBBS, Boston Children’s Hospital / Harvard Medical School

Kathy J. Jenkins, MD, MPH, Boston Children’s Hospital / Harvard Medical School

Kimberlee Gauvreau, ScD, Boston Children’s Hospital / Harvard Medical School

3:15 – 3:30 p.m. FDA Presentation

Donna Buckley, lead reviewer

John E. Stuhlmuller, clinical reviewer

3:30 – 5:45 p.m. Open Committee Discussion, Recommendations, Cynthia Tracy, M.D.
and Voting

4:00 – 4:15 p.m. Break

5:45 – 6:00 p.m.* Open Public Hearing*

6:00 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. Moynahan 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. Tracy will recognize unscheduled speakers as time allows.

There were no requests to speak during the Open Public Hearings on September 10. Megan Moynahan will summarize for the record several letters received on the topic of septal occluders.

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