DRAFT AGENDA

 

ORTHOPEDIC AND  REHABILITATION DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Holiday Inn

Walker and Whetstone Ballrooms

2 Montgomery Village Avenue

Gaithersburg, Maryland

December 11, 2003

 

Panel Chairperson                                                                                          Executive Secretary

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

 

  9:00       am                Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

                                Update Since the January Date, 2001 Meeting

Barbara C. Zimmerman, Chief, Orthopedics Devices Branch

 

Reclassification of the Intervertebral Body Fusion Device (Cage)

                                     

  9:15        am                FDA Presentation

Jodi H. Anderson, MS, Orthopedics Devices Branch

 

10:00       am                Industry Presentations                       

 

11:30       am                Break

 

11:45       am                Open Public Hearing, up to 60 minutes

 

12:45       pm                Lunch

 

 1:45        am                 Panel Deliberation

 

 3:45        pm                 Break

 

 4:00       pm                Panel Deliberation continued,

Reclassification Questionnaire and Supplemental Data Sheet, and Vote  

 

 6:00        pm                Adjournment

 

Notes

 

1. During the open public hearing, 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, Dr. Yaszemski may ask them to remain if the panel whishes to question them. Then Dr. Yaszemski will recognize unscheduled speakers as time allows.

 

 2. Only the panel may question speakers during the open public hearing