ORTHOPEDIC AND REHABILITATION DEVICES PANEL

Hilton Washington DC North

620 Perry Parkway

Gaithersburg, Maryland

September 8, 2005

 

Panel Chairperson                                                                                         Executive Secretary

John S. Kirkpatrick, M.D.                                                                              Janet L. Scudiero, M.S.

 

8:30        am                Call to Order

                                Panel Introductions

Conflict of Interest and Deputization to Voting Member Status Statements

Postmarket Study Design

      Susan N. Gardner, Ph.D., Director, Office of Surveillance and Biometrics

                                Update since the August 31, 2004 Meeting  

                                  Glenn A. Stiegman, Chief, Orthopedic Devices Branch

 

Smith and Nephew, Birmingham Hip Resurfacing (BHR) System, P040033

             

 9:15       am                1st Open Public Hearing*

                                     Orthopaedic Surgical Manufacturers’ Association, Susan Krasny 

                                     Wright Medical Technology, Inc., William Maloney, M.D

 

 9:45       am                Sponsor Presentation

                                     Marcos Velez-Duran, VP Clinical/Regulatory Affairs and Quality (Trauma)  

                                     Derek J.W. McMinn, FRCS, Orthopaedic Surgeon, Birmingham Nuffield Hospital

                                     Tim Band, Director Product Development

                                     George DeMuth, Statistical Consultant

                                     Neal Defibaugh, Director Clinical Affairs

 

10:45     pm                Break   

 

11:00     am                FDA Presentation        

                                     John S. Goode, M.S., Orthopedic Devices Branch

                                     Chang S. Lao, Ph.D., Division of Biostatistics, Office of Surveillance and Biometrics            

 

12:00     am                 Lunch

 

  1:00      pm                Panel Deliberations and FDA Questions

                                  Lead Discussant, Jay D. Mabrey, M.D.

 

  3:30      pm                2nd Open Public Hearing*

 

  4:00      pm                Break

 

  4:15      pm                FDA and Sponsor Summations        

 

  4:45      pm                Panel Vote

 

  6:00      pm                Adjournment      

* Open Public Hearings - Scheduled speakers who have requested time to address the panel will speak at this time.  After they have spoken, the Chair may ask them to remain if the panel wishes to question them. The Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.