Advisory Committees
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2011 Meeting Materials of the Circulatory System Devices Panel
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October 13, 2011: Meeting Materials FDA Generated
October 13, 2011: Meeting Agenda (PDF - 35KB)October 13, 2011: Final Voting Questions (DOC - 33KB)October 13, 2011: FDA Executive Summary (DOC - 2.5MB)October 13, 2011: Discussion Questions (DOC - 144KB)October 13, 2011: Public Roster (PDF - 8KB)October 13, 2011: Panel Presentation (PDF - 1.6MB)October 13, 2011: 24-Hour Summary (PDF - 123KB)- October 13, 2011: Transcript (PDF - 1.1MB)
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October 13, 2011: Meeting Materials (Non-FDA Generated)
October 13, 2011: Table of Contents (PDF - 20KB)October 13, 2011: Sponsor Executive Summary (PDF - 1.1MB)October 13, 2011: Proposed SSED (PDF - 1.1MB)October 13, 2011: Proposed Package Insert-Instructions for Use (PDF - 1MB)October 13, 2011: Proposed Patient Labeling-Patient Card (PDF - 152KB)October 13, 2011: Proposed Patient Labeling-Patient Guide (PDF - 2.7MB)October 13, 2011: Proposed Post - Approval Study (PDF - 182KB)- October 13, 2011: Clinical Study Reports (PDF - 43KB)
October 13, 2011: Clinical Study Reports - Attachment A1-Definitions (PDF - 65KB)October 13, 2011: Sponsor Presentation (PDF - 3.9MB)October 13, 2011: Open Public Meeting Comments Gray (PDF - 22KB)October 13, 2011: Open Public Meeting Comments McClenny (PDF - 69KB)
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July 21, 2011: Meeting Materials (Non-FDA Generated)
- July 21, 2011: Sponsor Executive Summary (PDF - 1.8MB)
July 21, 2011: Summary of Safety and Probable Benefit (PDF - 1.6MB)July 21, 2011:Post Approval Study Protocol (PDF - 785KB)July 21, 2011: Parent Brochure (PDF - 165KB)July 21, 2011: Instructions for Use (PDF - 5.9MB)July 21, 2011: Product Catalog (PDF - 3.2MB)July 21, 2011: Main Facts (PDF - 5.7MB)July 21, 2011: Component Insert (PDF - 340KB)July 21, 2011: Information Sheet (PDF - 234KB)July 21, 2011: Reference List (PDF - 135KB)July 21, 2011: Password List (PDF - 338KB)July 21, 2011: Supplementary Information Sheet (PDF - 42KB)July 21, 2011: Sponsor Presentation (PDF - 1.3MB)
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July 21, 2011: Meeting Materials (FDA Generated)
July 21, 2011: Agenda (PDF - 35KB)July 21, 2011: Public Roster (PDF - 10KB)July 21, 2011: FDA Executive Summary (PDF - 966KB)July 21, 2011: Panel Questions (PDF - 53KB)July 21, 2011: Voting Questions (PDF - 13KB)July 21, 2011: Bibliography (PDF - 3KB)July 21, 2011: 24 Hour Summary (PDF - 102KB)July 21, 2011: FDA Presentation (PDF - 5.8MB)July 21, 2011: FDA Post Approval Studies Update (PDF - 2.3MB)July 21, 2011: Transcript (PDF - 1018KB)
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July 20, 2011: Meeting Materials (Non-FDA Generated)
- July 20, 2011: Sponsor Executive Summary (PDF - 552KB)
July 20, 2011: Briefing Booklet (PDF - 2.9MB)July 20, 2011: Summary of Safety and Effectiveness (PDF - 982KB)July 20, 2011: Indications for Use (PDF - 449KB)July 20, 2011: Instructions for Use (PDF - 630KB)July 20, 2011: Package Labeling (PDF - 9.4MB)July 20, 2011: Patient Brochure (PDF - 1.5MB)July 20, 2011: Sponsor Presentation (PDF - 11.3MB)July 20, 2011: Written Comments - Pichard (PDF - 187KB)July 20, 2011: Written Comments - TAVI Statement (PDF - 639KB)July 20, 2011: OPH Comments - Holmes (PDF - 161KB)July 20, 2011: OPH Comments - Mack (PDF - 119KB)July 20, 2011: OPH Comments - Greer (PDF - 1.1MB)
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July 20, 2011: Meeting Materials (FDA Generated)
July 20, 2011: Agenda (PDF - 35KB)Borer Waiver (PDF - 35KB)Borer Acknowledgement (PDF - 16KB)July 20, 2011: Public Roster (PDF - 7KB)- July 20, 2011: FDA Executive Summary (PDF - 628KB)
July 20, 2011: Panel Questions (PDF - 67KB)July 20, 2011: Voting Questions (PDF - 59KB)July 20, 2011: Bibliography (PDF - 11KB)- July 20, 2011: 24 Hour Summary (PDF - 76KB)
- July 20, 2011: FDA Presentation (PDF - 510KB)
July 20, 2011: Transcript (PDF - 1.3MB)
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January 26, 2011: Meeting Materials Non-FDA Generated
Appendix 2 Literature Review (PDF - 9KB)Table of Contents (PDF - 12KB)Brott NEJM 2010 (PDF - 35KB)Brott Stroke 1984 (PDF - 52KB)Collaborators NASCET NEJM 1991 (PDF - 12KB)Panel Executive Summary (PDF - 71KB)Eckstein SPACE 2008 (PDF - 26KB)Summary of Safety and Effectiveness (PDF - 608KB)Ederle LANCET 2010 (PDF - 49KB)Executive Committee for ACAS JAM 1995 (PDF - 23KB)Post Market Protocol Summary (PDF - 76KB)Hobson Asym NEJM 1993 (PDF - 51KB)Moore AHA 1995 (PDF - 189KB)Ringleb SPACE Lancet 2006 (PDF - 22KB)Yadav SAPPHIRE NEJM 2004 (PDF - 57KB)IFU Update (PDF - 530KB)Section 1 0 Intro and Background (PDF - 182KB)Section 2 0 Summary of Protocol (PDF - 174KB)Section 3 0 Trial Conduct (PDF - 135KB)Section 4 0 Clinical Trial Regulations and Good Clinical (PDF - 25KB)Section 5 0 CREST Analyses (PDF - 677KB)Section 6 0 Summary of AEs (PDF - 204KB)Section 7 0 Summary of Protocol Compliance (PDF - 201KB)Section 8 0 Device Accountability (PDF - 36KB)Section Pre specified Appendix (PDF - 10KB)Crest Sponsor Presentation (PDF - 1.9MB)
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January 26, 2011: Meeting Materials FDA-Generated
Final Executive Summary (PDF - 2MB)Final Discussion Questions (DOC - 112KB)Voting Questions (DOC - 36KB)Roster (PDF - 17KB)Final Panel Member Biosketch (PDF - 32KB)January 26, 2011: Meeting Agenda (PDF - 16KB)January 26, 2011: 24 Hour Summary (PDF - 97KB)January 26, 2011: Transcript (PDF - 838KB)CREST FDA Presentation (PDF - 695KB)
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January 25, 2011: Meeting Materials
Executive Summary for 1/25/11 (PDF - 87KB)Panel Questions for 1/25/11 (PDF - 17KB)Meeting Agenda: January 25, 2011 (PDF - 24KB)Panel Member Biosketch (PDF - 32KB)Public Roster: January 25, 2011 (PDF - 14KB)January 25, 2011: 24 Hour Summary (PDF - 88KB)January 25, 2011: Transcript (PDF - 936KB)
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