Advisory Committees
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2010 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel
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July 27, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (Non-FDA Generated)
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July 27, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (FDA Generated)
July 27, 2010 Meeting Agenda (PDF - 34KB)July 27, 2010 Meeting Roster (DOC - 39KB)July 27, 2010 FDA Executive Summary (PDF - 806KB)July 27, 2010 Panel Questions (PDF - 21KB)24-Hour Meeting Summary (PDF - 21KB)FDA Panel Questions (PDF - 40KB)Post-Approval Studies Program Update (PDF - 959KB)AMPLIFY ™ rhBMP rhBMP-2 Matrix FDA Presentation (PDF - 547KB)July 27, 2010: Meeting Transcript (PDF - 800KB)
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March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (Non-FDA Generated)
Regen Executive Summary (PDF - 6MB)Regen 510K Summary (PDF - 70KB)Redacted Cleared Package Insert (PDF - 192KB)Redacted Surgical Technique from IDE (PDF - 929KB)Regen CS Instructions for Use (PDF - 108KB)Predicate Mesh Comparison Table (PDF - 78KB)Depuy Restore Instructions for Use (PDF - 659KB)Acute Study Arm Protocol (PDF - 1.6MB)Chronic Study Arm (PDF - 1.6MB)Part 1 - IDE Study CRFs (PDF - 449KB)Part 2 - IDE Study CRFs (PDF - 449KB)JBJS Article (PDF - 5KB)Rodeo JBJS Commentary and Perspective (PDF - 5KB)Becker 2006 final (PDF - 5KB)Krause Meniscus 1976 Final (PDF - 5KB)Parsons Shoulder Joint 2002 Final (PDF - 5KB)Fithian Meniscus Properties 1990 Final (PDF - 5KB)CMI Feasibility Trial 2 year follow-up Final (PDF - 5KB)Feasibility Trial 5-6 yr Follow-up Final (PDF - 5KB)European Feasibility Article Final (PDF - 5KB)Briggs 2006 Final (PDF - 5KB)Open Public Meeting Presentation (PDF - 31KB)ReGen Presentation (PDF - 4.3MB)
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March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Materials (FDA Generated)
Regen 24-Hour Summary Torzilli Waiver (PDF - 22KB)Torzilli Acknowledgement (PDF - 18KB)Redacted 2008 Panel Transcript (PDF - 391KB)Meeting Agenda (DOC - 54KB)Meeting Roster (DOC - 34KB)Panel Questions (PDF - 35KB)510(k) SE Flowchart (PDF - 32KB)FDA Executive Summary (PDF - 900KB)FDA ReGen Presentation (PDF - 1.3MB)March 23, 2010 Meeting Transcript (PDF - 1MB)
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