ORTHOPEDIC AND REHABILITATION DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Gaithersburg Hilton 

620 Perry Parkway

Gaithersburg, Maryland

August 31, 2004

 

Panel Chairperson                                                                                         Executive Secretary

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

 

 8:00       am                Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

                                Update since the June 2 and 3, 2004 Meeting

Barbara C. Zimmerman, Chief, Orthopedic Devices Branch  

 

St. Francis Medical Technologies, Inc.

Intraspinous Process Distraction System, the X STOP^®, P040001

                 

 8:15       am                1^st Open Public Hearing*                

 

 8:45       am                Sponsor Presentation

                                                Yvonne Lysakowski, R.N., M.S., Vice President, Regulatory & Clinical Affairs

St. Francis Medical Technologies, Inc., Alameda, CA

 

Augustus A. White III, M.D., Ph.D., Orthopedic Surgeon-in Chief, Emeritus

Beth Israel Deaconess Medical Center and

Professor, Orthopedic Surgery, Harvard Medical School, Boston, MA

 

Scott Yerby, Ph.D., Director, Research & Development

St. Francis Medical Technologies, Inc., Alameda, CA

 

Gunnar Andersson, M.D., Ph.D., Senior Vice President, Medical Affairs

Professor, Department of Orthopedic Surgery

Rush University Medical Center, Chicago, IL

 

Charles Hartjen, M.D., Medical Director, The Spine Center at GBMC

Greater Baltimore Medical Center, Baltimore, MD

 

 9:45       am                FDA Presentation                                                        

                                                John P. Holden, Ph.D., Biomedical Engineer

Barbara D. Buch, M.D., Medical Officer

                                                Richard M. Kotz, M.S., Statistician

                                               

10:45     pm                 Break  

 

11:00     pm                Panel Deliberations and FDA Questions

                                               

12:00     am                Lunch

 

 

1:00        pm                Panel Deliberations, including FDA Questions

                                                John S. Kirkpatrick, M.D.

                                               

  2:30      pm                2^nd Open Public Hearing

 

  3:00      pm                FDA and Sponsor Summations, up to 15 minutes each       

 

  3:30      pm                Panel Vote

 

  4:30      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. Then the Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.