Advisory Committees
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2012 Meeting Materials of the Neurological Devices Panel
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December 10, 2012: Meeting Materials FDA Generated
Agenda: December 10, 2012 (PDF - 16KB)- Roster: December 10, 2012 (PDF - 20KB)
FDA Executive Summary: December 10, 2012 (PDF - 994KB)Panel Questions: December 10, 2012 (PDF - 19KB)24 Hour Summary: December 10, 2012 (PDF - 39KB)FDA CoAxia Presentation (PDF - 347KB)Transcript: December 10, 2012 (PDF - 947KB)
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December 10, 2012: Meeting Materials Non-FDA Generated
CoAxia Executive Summary (PDF - 1.7MB)CoAxia Device Description (PDF - 26KB)CoAxia Clinical Study Reoprt Vol I (PDF - 2.5MB)CoAxia Clinical Study Reoprt Vol II (PDF - 1.1MB)CoAxia Clinical Study Reoprt Vol III (PDF - 6.9MB)CoAxia Presentation (PDF - 7MB)CoAxia Panel Questions Responses (PDF - 330KB)
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March 23, 2012: Meeting Materials FDA Generated
Agenda . (PDF - 63KB)Roster . (PDF - 10KB)Furie Waiver (PDF - 83KB)Furie Acknowledgement (PDF - 16KB)Goldstein Waiver (PDF - 83KB)Goldstein Acknowledgement (PDF - 16KB)Sung Waiver (PDF - 84KB)Sung Acknowledgement (PDF - 21KB)DRAFT FDA Panel Questions (PDF - 52KB)FDA Executive Summary for Wingspan (PDF - 221KB)FDA Executive Summary Reference 1 (PDF - 54KB)FDA Executive Summary Reference 2 (PDF - 199KB)FDA Executive Summary Reference 3 (PDF - 199KB)FDA Executive Summary Reference 4 (PDF - 8KB)- FDA Executive Summary Reference 5 (PDF - 10KB)
FDA Executive Summary Reference 6 (PDF - 8KB)FDA Executive Summary Reference 7 (PDF - 10KB)FDA Executive Summary Reference 8 (PDF - 10KB)FDA Executive Summary Reference 9 (PDF - 29KB)FDA Executive Summary Reference 10 (PDF - 9KB)FDA Executive Summary Reference 11 (PDF - 10KB)FDA Executive Summary Reference 12 (PDF - 9KB)FDA Executive Summary Reference 13 (PDF - 9KB)FDA Executive Summary Reference 14 (PDF - 9KB)FDA Executive Summary Reference 15 (PDF - 11KB)Citizen Petition to FDA (PDF - 432KB)Adverse Medical Device Reports (PDF - 9KB)Wingspan Summary (PDF - 36KB)FDA Presentation: Part 1 (PDF - 235KB)FDA Presentation: Part 2 (PDF - 437KB)24 - Hour Summary (PDF - 116KB)Transcript. (PDF - 1.3MB)
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March 23, 2012: Meeting Materials Non-FDA Generated
Stryker Executive Summary (PDF - 237KB)- SSPB Wingspan (PDF - 521KB)
DFU Gateway (PDF - 273KB)DFU Wingspan (PDF - 545KB)- Patient Brochure Wingspan (PDF - 514KB)
- Appendix A.1 - Clinical Publication (PDF - 10KB)
- Appendix A.2 - Clinical Publication (PDF - 108KB)
- Appendix A.3 - Clinical Publication (PDF - 55KB)
- Appendix A.4 - Clinical Publication (PDF - 13KB)
- Appendix A.5 - Clinical Publication (PDF - 8KB)
- Appendix A.6 - Clinical Publication (PDF - 9KB)
- Appendix A.7 - Clinical Publication (PDF - 8KB)
- Appendix A.8 - Clinical Publication (PDF - 9KB)
- Appendix A.9 - Clinical Publication (PDF - 9KB)
- Appendix A.10 - Clinical Publication (PDF - 8KB)
- Appendix A.11 - Clinical Publication (PDF - 9KB)
- Appendix A.12 - Clinical Publication (PDF - 9KB)
Appendix A References (PDF - 8KB)- Appendix C - SAMMPRIS Eligibility Criteria (PDF - 51KB)
- Appendix B - HDE Study Eligibility Criteria (PDF - 13KB)
- Appendix D - Data and Literature Analysis (PDF - 27KB)
- Appendix E - ESASIS (PDF - 11KB)
- Appendix F - 21 U.S.C. (PDF - 82KB)
- Appendix F - SSPB Wingspan (PDF - 521KB)
- Appendix F - 21 CFR 814.214 (PDF - 30KB)
- Appendix F - Guidance for HDE Holders (PDF - 113KB)
Appendix F - 21 CFR 814.126 (PDF - 31KB)Appendix F - 21 CFR 814 Part 803 (PDF - 100KB)Appendix F - 21 CFR 814.214 (PDF - 30KB)Appendix F - 21 CFR 803 (PDF - 100KB)Appendix F - 21 CFR 806 (PDF - 46KB)Appendix F - 21 CFR 814.104 (PDF - 33KB)Appendix F - 21 CFR 814.126a (PDF - 37KB)SAMMPRIS Executive Summary - NEJM paper (PDF - 51KB)SAMMPRIS Executive Summary - Medical Failure Presentation (PDF - 1KB)Stryker Presentation (PDF - 9.4MB)SAMMPRIS Presentation (PDF - 435KB)
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February 10, 2012: Meeting Materials FDA Generated
Meeting Agenda (PDF - 35KB)Panel Roster. (PDF - 8KB)Pascual-Leone Waiver: Alvaro Pascual-Leone, M.D., Ph.D. was unable to attend this meeting (PDF - 86KB)Pascual-Leone Acknowledgment (PDF - 39KB)Panel Questions (PDF - 50KB)FDA Executive Summary (PDF - 637KB)FR Notice - Proposed Rules (PDF - 351KB)- Panel Regulatory Reference Sheet (PDF - 17KB)
Presentation: Device Reclassification Intro (PDF - 147KB)Presentation: Regulatory Background (PDF - 354KB)Presentation: FDA (PDF - 354KB)Presentation: FDA Back-up Slides (PDF - 207KB)24-Hour Summary (PDF - 109KB)Transcript (PDF - 1.1MB)Transcript: Addendum (PDF - 54KB)
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February 10, 2012: Meeting Materials Non-FDA Generated
Petition: Electromedical Products International, Inc. (PDF - 12.7MB)Petition: Fisher Wallace Laboratories, LLC (PDF - 1.7MB)Petition: Neuro-Fitness (PDF - 2.3MB)Presentation: Electromedical Products International, Inc. (PDF - 1.1MB)Presentation: Fisher Wallace Laboratories, LLC (PDF - 666KB)Presentation: Neuro-Fitness (PDF - 1.3MB)
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