Food and Drug Administration

Orthopedic and Rehabilitation Devices Panel

of the Medical Devices Advisory Committee

August 31, 2004

Briefing Information

X-Stop Interspinous Process Distraction System

Panel Recommendation Options for Premarket Approval Applications (HTM) (PDF) (Word)

FDA Clinical Summary Review Memorandum (HTM) (PDF) (Word)

Disclaimer

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.

X-Stop Case Report Form, St. Francis Medical Technologies, Inc. (HTM) (PDF) (Word)

Final Statistical Review (HTM) (PDF) (Word)