DRAFT  

 

ORTHOPAEDIC AND REHABILITATION DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Gaithersburg Marriott 

Salons A, B, C, and D

9751 Washingtonian Boulevard

Gaithersburg, Maryland

June 2, 2004

 

Panel Chairperson                                                                                          Executive Secretary

Michael J. Yaszemski, M.D., Ph.D.                                                       Janet L. Scudiero, M.S., acting

 

10:00       am                Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

                                Update since the December 11, 2003 Meeting

 

DePuy Spine, Inc., Charité Artificial Lumbar Disc, P040006

                 

10:15       am                1st Open Public Hearing*

                               

10:45       am                Sponsor Presentation                                         

 

11:45       am                FDA Presentation                                                         

                                               

12:30       pm                 Lunch

 

  1:30       pm                Panel Deliberation and FDA Questions

                                               

 

  3:30       pm                2nd Open Public Hearing

 

  4:00       pm                Break

 

  4:15       pm                FDA and Sponsor Summations, up to 15 minutes each 

 

  4:45       pm                Panel Vote

 

  6:00       pm                Adjournment                      

 

* Open Public Hearings – Interested persons may present data, information, or views, orally or in writing, on the issue pending before the panel.  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. Then the Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.