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Food and Drug Administration

Orthopaedic and Rehabilitation Devices Panel

July 15, 2008

BRIEFING INFORMATION

FzioMed Oxiplex/SP Gel, P070023

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.

Sponsor Executive Summary (pdf)  
   
Proposed SSED (pdf)

Proposed Surgical Technique (pdf)

Proposed Package Insert (pdf)

Proposed Patient Labeling (pdf)

Post-Approval Study Rationale (pdf)

FDA

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 space on the screen or on the printed page.

FDA Executive Summary (pdf)

Page last updated July 7, 2008 kkhorizonal rule
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