Advisory Committees
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2011 Meeting Materials of the Circulatory System Devices Panel - continued
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December 8, 2011: Meeting Materials (FDA Generated)
- Agenda 12/8/11 (PDF - 35KB)
Roster 12/8/11 (PDF - 8KB)FDA Executive Summary 12/8/11 (PDF - 1014KB)FDA Executive Summary - Addendum 12/8/11 (PDF - 90KB)Panel Questions 12/8/11 (PDF - 107KB)Voting Questions 12/8/11 (PDF - 64KB)24 Hour Summary: 12/8/11 (PDF - 76KB)FDA Panel Slides: 12/8/11 (PDF - 2.3MB)Transcript 12/8/11 (PDF - 1.3MB)
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December 8, 2011: Meeting Materials (Non-FDA Generated)
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December 7, 2011: Meeting Materials (FDA Generated)
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December 7, 2011: Meeting Materials (Non-FDA Generated)
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October 27, 2011: Meeting Materials (FDA Generated)
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October 27, 2011: Meeting Materials (Non-FDA Generated)
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October 26, 2011: Meeting Materials (FDA Generated)
Agenda: Oct. 26, 2011 (PDF - 35KB)Roster: Oct. 26, 2011 (PDF - 26KB)FDA Executive Summary: Oct. 26, 2011 (PDF - 1.7MB)Panel Questions: Oct. 26, 2011 (PDF - 245KB)- Voting Questions: Oct. 26, 2011 (PDF - 93KB)
- FDA Presentation: AtriCure (PDF - 1.2MB)
24 Hour Summary: October 26, 2011 (PDF - 123KB)Transcript: October 26, 2011 (PDF - 1MB)
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October 26, 2011: Meeting Materials (Non-FDA Generated)
Panel Pack Executive Summary (PDF - 2MB)Proposed SSED (PDF - 888KB)Proposed Package Insert 01 (PDF - 627KB)- Proposed Package Insert 02 (PNG - 122KB)
Proposed Package Insert 03 (PNG - 121KB)Proposed Post Approval Study (PDF - 7KB)Proposed Training Outline of AtriCure Training Plan (PDF - 117KB)Training Attachment 1 (PDF - 8KB)Training Attachment 2 (PDF - 8KB)Appendix A (PDF - 8KB)Appendix B (PDF - 8KB)Appendix C (PDF - 8KB)Appendix D (PDF - 8KB)Appendix E (PDF - 8KB)Appendix F (PDF - 8KB)Appendix G (PDF - 784KB)Appendix H (PDF - 51KB)Appendix I (PDF - 8KB)Appendix J (PDF - 153KB)Appendix K (PDF - 8KB)Appendix L (PDF - 8KB)Appendix M (PDF - 315KB)Appendix N (PDF - 294KB)Appendix O (PDF - 203KB)Presentation: AtriCure (PDF - 1.6MB)STS Statement (PDF - 177KB)
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