Advisory Committees
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2011 Meeting Materials of the General and Plastic Surgery Advisory Panel
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August 30-31, 2011: Meeting Materials Non-FDA Generated
Appendix A (PDF - 2.5MB)Appendix B - Protocol (PDF - 2MB)Appendix B - Core Study (PDF - 2.4MB)Appendix B - Adjunct PAS Plan (PDF - 97KB)Appendix B - Focus Group Post Approval (PDF - 324KB)Appendix C - Core Gel Protocol (PDF - 1.7MB)Appendix C - Focus Group Study Protocol (PDF - 200KB)Appendix C - Memory Gel PAS Protocol (PDF - 213KB)Appendix C - Adjunct Protocol (PDF - 44.8MB)- Mentor PAS Presentation (PDF - 518KB)
Allergan PAS Presentation (PDF - 1018KB)TONABA Press Release (PDF - 84KB)Testimony (PDF - 39KB)
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August 30-31, 2011: Meeting Materials FDA-Generated
Cover Letter (PDF - 59KB)Agenda. (PDF - 42KB)Roster (PDF - 10KB)Panel Questions (PDF - 18KB)FDA Executive Summary (PDF - 336KB)Appendix D - Allergan SSED (PDF - 290KB)Appendix E - Mentor SSED (PDF - 412KB)Appendix F - FDA Update on the Safety of Silicone Gel-Filled Breast Implants (PDF - 1.1MB)Appendix G - ALCL White Paper (PDF - 289KB)FDA Presentation: Dabic (PDF - 2.5MB)FDA Presentation: Krulewitch and Topaloglu (PDF - 384KB)24-Hour Summary (PDF - 126KB)Transcript: Aug. 30, 2011 (PDF - 1.2MB)Transcript: Aug. 31, 2011 (PDF - 979KB)
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April 27, 2011 Meeting Materials Non-FDA Generated
- Sponsor Cover Letter (PDF - 87KB)
Panel Track Supplement (PDF - 88KB)- Restylane SSED (PDF - 381KB)
Protocol (PDF - 511KB)Restylane IFU (PDF - 508KB)Restylane Patient Labeling Brochure (PDF - 186KB)Patient Labeling Text (PDF - 104KB)Sponsor Executive Summary (PDF - 1016KB)Indication from the Panel Track Summary (PDF - 88KB)Telecon Meeting Minutes (PDF - 97KB)Restylane Presentation (PDF - 4.7MB)
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April 27, 2011 Meeting Materials FDA-Generated
- April 27, 2011: Meeting Agenda (DOC - 31KB)
- April 27, 2011: Meeting Roster (DOC - 54KB)
April 27, 2011: FDA Executive Summary (PDF - 208KB)- April 27, 2011: Addendum to FDA Executive Summary (PDF - 138KB)
- April 27, 2011: Panel Questions (PDF - 74KB)
Panel Questions Presentation (PDF - 178KB)FDA Presentation (PDF - 76KB)24 - Hour Summary (PDF - 75KB)Transcript (PDF - 986KB)
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