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
Robert L. McCauley, MD, Acting Chairman
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
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