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

July 24, 2003

 

Panel Acting Chair:                                                                          Executive Secretary:

Robert L. McCauley, MD                                                                                                         David Krause, PhD

 

 

8:00 am                 Closed Session

 

                                Update Regarding Future Submissions
                                Neil R. P. Ogden, Branch Chief, General Surgery Devices Branch

 

8:30 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

Open Public Comment

9:00 am                Reclassification of Absorbable Hemostatic Agents and Dressings

Industry Presentation

John D. Paulson, PhD, Vice President Quality Assurance and Regulatory Affairs,
Johnson & Johnson Wound Management a Division of Ethicon, Inc.

Ms. Lene Retbǿll Műller, Director of Quality Assurance, Medical Devices, Ferrosan A/S

Judith E. O’Grady, RN, MSN, RAC, Senior Vice President, Regulatory, Quality and Clinical Affairs, Integra LifeSciences Corporation

 

10:00 am                FDA Presentation

                                David Krause, PhD, Division of General, Restorative & Neurological Devices/ODE

 

10:30 am                Break

 

11:00 am                Open Public Comment

 

11:15 am                Panel Deliberations and Address FDA Questions

                                Reclassification Questionnaire and Vote
                               
Mr. Robert Gatling, Office of Device Evaluation

 

12:00 am                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

 

Open Public Comment

 

1:45 pm                 General Topic Discussion

Clinical Issues in Regards to Medical Devices for the Percutaneous Removal of Breast Tumors

 

FDA Presentation

Binita S. Ashar, MD, Division of General, Restorative & Neurological Devices

Industry Presentations:

Kelsey, Inc.

 

3:00 pm                 Open Panel Discussion and FDA Questions

 

 5:00 pm                Adjournment