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Advisory Committees
2009 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel
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November 4, 2009 Meeting Materials-- Non-FDA Generated Materials
- Accessibility Instructions
- Draft Dynesys Instructions for Use (PDF - 608KB)
- Dynesys Safety and Effectiveness Data (PDF - 277KB)
- Executive Summary (PDF - 1190KB)
- Exhibit A (PDF - 250KB)
- Exhibit B (PDF - 434KB)
- Exhibit C (PDF - 454KB)
- Exhibit D (PDF - 463KB)
- Exhibit E (PDF - 470KB)
- Dynesys Surgical Technique (PDF - 2136KB)
- Dynesys Non-Fusion PMA Patient Brochure (PDF - 623KB)
- Zimmer Final Presentation (PDF - 3379KB)
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November 4, 2009 Meeting Materials-- FDA Generated Materials
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August 18-19, 2009 Meeting Materials
- Acknowledgement of Waiver (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 44KB)
- Waiver (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 105KB)
- Agenda (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 91KB)
- Meeting Roster (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 60KB)
- Agenda Day 2 (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 90KB)
- Meeting Roster Day 2 (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 61KB)
- Draft Questions 1 (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 78KB)
- Draft Questions 2 (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 46KB)
- Depuy Panel Pack Amendment (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 794KB)
- Depuy Attachment A (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 2186KB)
- Depuy Attachment B (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 1723KB)
- Depuy Attachment C (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 820KB)
- Depuy Attachment D (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 1305KB)
- PMA Submission History (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 836KB)
- PMA Voting Options (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 15KB)
- Proposed Draft Patient Information (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 673KB)
- Proposed Draft Physician Instructions for Use (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 2859KB)
- Executive Summary (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 640KB)
- Executive Summary 2 (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 364KB)
- Summary of Safety and Effectiveness Data (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 5485KB)
- Ancillary Analyses (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 12969KB)
- Pivotal Study Protocol (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 16589KB)
- Sponsor Executive Summary (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 15292KB)
- Brief Summary (August 18-19, 2009: Orthopaedic and Rehabilitation Devices Panel)
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March 31, 2009 Meeting Materials
- Agenda (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 8KB)
- Roster (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel) (PDF - 8KB)
- Questions (March 31, 2009: Orthopaedics and Rehabilitation Devices Panel Meeting) (PDF - 14KB)
- Briefing Information (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting)
- Slide Presentations (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting)
- Transcript Part 1 (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting) (PDF - 267KB)
- Transcript Part 2 (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting) (PDF - 261KB)
- Transcript Part 3 (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting) (PDF - 261KB)
- Transcript Part 4 (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting) (PDF - 56KB)
- Summary (March 31, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting)
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