Food and Drug Administration

Orthopaedic and Rehabilitation Devices Panel

November 21, 2002



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

rhBMP-2 soaked Absorbable Collagen Sponge (ACS) for the treatment of Open Tibial Shaft Fractures (PPT)

The Orthopedic & Rehabilitation Device Advisory Panel Meeting (November 21, 2002)
Statistical Issues for PMA P000054, Dr. Chang S. Lao, Ph.D., FDA (HTM) (PPT)

Pharmaceuticals, Inc. InductOs (rhBMP-2/ACS Device), FDA (HTM) (PPT)

Panel Questions (HTM) (PPT)