Advisory Committees
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2011 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel
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May 12, 2011: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (FDA Generated)
May 12, 2011: Agenda (DOC - 31KB)May 12, 2011: Roster (DOC - 77KB)May 12, 2011: FDA Executive Summary (PDF - 809KB)May 12, 2011: Panel Questions (PDF - 37KB)May 12, 2011: Package Insert (PDF - 129KB)May 12, 2011: Patient Labeling (PDF - 309KB)May 12, 2011: PAS-Toxicology (PDF - 136KB)- May 12, 2011: 24-Hour Summary (PDF - 64KB)
May 12, 2011: FDA Presentation (PDF - 428KB)May 12, 2011: FDA Prensentation - Marinac-Dabic (PDF - 151KB)- May 12, 2011: Addendum to FDA's Panel Package (PDF - 89KB)
May 12, 2011: Meeting Transcript (PDF - 1.1MB)
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May 12, 2011: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (Non-FDA Generated)
May 12, 2011: Sponsor Cover Page (PDF - 49KB)May 12, 2011: Sponsor SSED (PDF - 342KB)May 12, 2011: Sponsor Summary Intro (PDF - 8KB)May 12, 2011: Sponsor Preclinical Summary (PDF - 99KB)May 12, 2011: Sponsor Pharmacology Summary (PDF - 468KB)May 12, 2011: Sponsor Pharmacokinetics Summary (PDF - 673KB)May 12, 2011: Sponsor Toxicology Summary (PDF - 247KB)May 12, 2011: Sponsor Clinical Study BMTI-2005-03 (PDF - 102KB)May 12, 2011: Sponsor Clinical Study BMTI-2005-04 (PDF - 98KB)May 12, 2011: Sponsor Abbreviated Clinical Study BMTI-2006-03-EU (PDF - 109KB)May 12, 2011: Sponsor Clinical Study BMTI-2006-01 (PDF - 230KB)May 12, 2011: Sponsor PAS-Clinical (PDF - 337KB)May 12, 2011: Sponsor Response to Deficiencies (PDF - 2.2MB)May 12, 2011: Sponsor Appendix (PDF - 17KB)May 12, 2011: Sponsor Presentation (PDF - 7.4MB)May 12, 2011: Sponsor Letter from University Orthopedics Study Group (PDF - 784KB)May 12, 2011: Sponsor Letter from University of Southern California (PDF - 63KB)
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