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Food and Drug Administration

Orthopedic and Rehabilitation Devices Panel Meeting

December 9, 2008

BRIEFING INFORMATION

FDA

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.

FDA Executive Summary (pdf)

Voting Options (pdf)

FDA Questions (pdf)

 

Sponsor

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).  These redacted portions will appear as white spaces on the screen or on the printed page.

2008-4404b1 Sponsors Executive Summary (pdf)

2008-4404b1-02 Current Synvisc Package Insert (pdf)

2008-4404b1-03 Proposed Synvisc –One Package Insert (pdf)

2008-4404b1-04 Proposed Summary of Safety and Effectiveness (pdf)

2008-4404b1-05 WOMAC Questionnaire (pdf)

2008-4404b1-06 Final Clinical Protocol (pdf)

2008-4404b1-07 Final Statistical Analysis Plan (pdf)

Page last updated December 3, 2008 kkhorizonal rule
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