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Orthopaedic and Rehabilitation Devices Panel
July 15, 2008
FzioMed Oxiplex/SP Gel, P070023
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)
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)