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 1st 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 2nd Open Public Hearing

 

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

 

3:30 pm Panel Vote

 

4:30 pm Adjournment