AGENDA

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Salons A, B, & C, Grand Ballroom

Gaithersburg Hilton Hotel

620 Perry Parkway, Gaithersburg, Maryland

February 28, 2003

 

Panel Acting Chair:                                                                          Executive Secretary:

Robert L. McCauley, MD                                                                                                         David Krause, PhD

 

 

8:00 am                 Call to Order

 

Conflict of Interest and Opening Remarks

David Krause, PhD, Executive Secretary

 

Panel Introductions

Robert L. McCauley, MD, Acting Chairman

 

Update Since the Last Meeting

Stephen P. Rhodes, MA, Branch Chief, Plastic and Reconstructive Surgery Devices Branch

8:30 am                 Open Public Comment (up to 15 minutes)

 

8:45 am                 Applicant Presentation

 

9:45 am                 FDA Presentation

 

10:15 am                Break

 

10:30 am                Panel Deliberations and Address FDA Questions

 

11:30 am                Open Public Comments (up to 15 minutes)

 

11:45 am                FDA Summation

 

                                Sponsor Summation

 

12:00 pm               Concluding Panel Deliberations and Vote

 

12:30 pm                Lunch

 

1:15 pm                 Call to Order

 

Conflict of Interest and Opening Remarks

David Krause, PhD, Executive Secretary

 

Panel Introductions

Robert L. McCauley, MD, Acting Chairman

 

1:30 pm                 General Topic Discussion

Clinical Issues in Regards to Medical Devices for the Treatment of Emphysema

 

FDA Presentation

 

Industry Presentations:

Broncus Technologies, Inc.

Closure Medical, Inc.

Emphasys Medical, Inc.

Spiration, Inc.

 

2:45 pm                 Open Public Comments (up to 15 minutes)

 

3:00 pm                 Open Panel Discussion and FDA Questions

 

3:30 pm                 General Topic Discussion

Clinical Issues in Regards to Devices used to Ablate Lung Tumors

 

FDA Presentation

 

Industry Presentation:

RITA Medical Systems, Inc.

 

4:00 pm                 Open Public Comments (up to 15 minutes)

 

4:15 pm                 Open Panel Discussion and FDA Questions

 

 5:00 pm                Adjournment