Food and Drug Administration
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)