Advisory Committees
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2012 Meeting Materials of the Circulatory System Devices Panel
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December 5-6, 2012: Meeting Materials FDA Generated
Agenda: Dec. 5, 2012 (PDF - 26KB)Agenda: Dec. 6, 2012 (PDF - 24KB)Roster: Dec. 5, 2012 (PDF - 22KB)Roster: Dec. 6, 2012 (PDF - 20KB)Introduction and Regulatory Reference Sheet (PDF - 48KB)ECP 515i Executive Summary (PDF - 151KB)IABP 515i Executive Summary (PDF - 448KB)NRP 515i Executive Summary (PDF - 401KB)ECP - 515i Panel Questions (PDF - 35KB)IABP - 515i Panel Questions (PDF - 25KB)NRP - 515i Panel Questions (PDF - 71KB)NRP - 1995 Transcript Open Session (PDF - 6.9MB)24 Hour Summary: December 5, 2012 (PDF - 55KB)24 Hour Summary: December 6, 2012 (PDF - 95KB)- FDA Presentation - ECP 515i (PDF - 485KB)
- FDA Presentation - IABP 515i (PDF - 488KB)
- FDA Presentation - NRP 515i (PDF - 1.7MB)
Device Reclassification Panel (PDF - 211KB)Transcript: Dec. 5, 2012 (A.M.) (PDF - 589KB)Transcript: Dec. 5, 2012 (P.M.) (PDF - 515KB)Transcript: Dec. 6, 2012 (PDF - 1.1MB)
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December 5-6, 2012: Meeting Materials Non-FDA Generated
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June 13, 2012: Meeting Materials FDA Generated
Agenda: June 13, 2012 (PDF - 35KB)Public Roster: June 13,2012 (PDF - 15KB)FDA Excutive Summary: June 13, 2012 (PDF - 755KB)- Panel Questions: June 13, 2012 (PDF - 115KB)
Voting Questions: June 13, 2012 (PDF - 68KB)- Waiver: Jeffrey S. Borer, M.D (PDF - 86KB)
- Acknowledgement: Jeffrey S. Borer, M.D (PDF - 14KB)
24 Hour Summary: June 13, 2012 (PDF - 91KB)Presentation Cardiovascular Panel: June13, 2012 (PDF - 1MB)Presentation FDA Slides: June 13, 2012 (PPT - 3.5MB)Transcript: June 13, 2012 (PDF - 3.3MB)
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June 13, 2012: Meeting Materials Non-FDA Generated
Sponsor Executive Summary - June 13, 2012 (PDF - 690KB)Briefing Book (PDF - 3.9MB)Summary of Safety and Effectiveness Data (PDF - 1.1MB)Indications for Use (PDF - 457KB)- Instructions for Use (PDF - 2.1MB)
Package Labeling (PDF - 12.6MB)- Patient Brochure (PDF - 1.6MB)
- Training Summary (PDF - 463KB)
- Presentation: Edwards AdCom (PDF - 1.2MB)
Presentation: NPAF (PDF - 367KB)Presentation: STS (PDF - 738KB)
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May 24, 2012: Meeting Materials FDA Generated
Agenda: May 24, 2012 (PDF - 36KB)Panel Roster: May 24, 2012 (PDF - 36KB)- Waiver: Richard A. Jonas, M.D. (PDF - 25KB)
- Acknowledgement: Richard A. Jonas, M.D. (PDF - 14KB)
- Waiver: Kenneth G. Zahka, M.D. (PDF - 26KB)
- Acknowledgement: Kenneth G. Zahka, M.D. (PDF - 14KB)
- FDA Executive Summary: May 24, 2012 (PDF - 1.2MB)
FDA Executive Summary Appendices: May 24, 2012 (PDF - 408KB)Panel Questions: May 24, 2012 (PDF - 28KB)ACC ASD Safety Statement (PDF - 785KB)AHA Statement (PDF - 105KB)SCAI Statement (PDF - 364KB)STS and AATS Statement (PDF - 60KB)24 Hour Summary: May 24, 2012 (PDF - 39KB)FDA Presentation: May 24, 2012 (PDF - 2.6MB)- Transcript: May 24, 2012 (PDF - 1.4MB)
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May 24, 2012: Meeting Materials Non-FDA Generated
Sponsor Gore: Attachment 1 (PDF - 10KB)Sponsor Gore: Attachment 2 (PDF - 13KB)Sponsor Gore: Attachment 3 (PDF - 1.6MB)Sponsor Gore: Attachment 5 ASD Animation (WMV - 21.6MB)Sponsor Gore: Attachment 6 SSED (PDF - 1.6MB)Sponsor Gore: Attachment 8 (PDF - 12KB)Sponsor Gore: Attachment 9 (PDF - 21KB)Sponsor Gore: Attachment 10 (PDF - 15KB)Sponsor Gore: Attachment 11 (PDF - 111KB)Sponsor Gore: Panel Pack (PDF - 591KB)Sponsor St. Jude: Panel Pack (PDF - 584KB)Sponsor St. Jude: Attachment 1 (PDF - 11KB)Sponsor St. Jude: Attachment 2 (PDF - 7KB)Sponsor St. Jude: Attachment 3 (PDF - 12KB)Sponsor St. Jude: Attachment 4 (PDF - 12KB)Sponsor St. Jude: Attachment 5 (PDF - 13KB)Sponsor St. Jude: Attachment 6 (PDF - 18KB)Sponsor St. Jude: Attachment 7 (PDF - 11KB)Sponsor St. Jude: Attachment 8 (PDF - 12KB)Sponsor St. Jude: Attachment (PDF - 9KB)Presentation: Gore (PDF - 1.6MB)Presentation: St. Jude (PDF - 546KB)
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April 25, 2012: Meeting Materials FDA Generated
Agenda: April 25, 2012 (PDF - 35KB)Roster: April 25, 2012 (PDF - 7KB)FDA Executive Summary: April 25, 2012 (PDF - 897KB)- Panel Questions: April 25, 2012 (PDF - 74KB)
Voting Questions: April 25, 2012 (PDF - 14KB)- 24 Hour Summary: April 25, 2012 (PDF - 73KB)
FDA Presentation: April 25, 2012 (PDF - 1.6MB)Transcript: April 25, 2012 (PDF - 1.2MB)
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April 25, 2012: Meeting Materials Non-FDA Generated
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April 26, 2012: Meeting Materials FDA Generated
Agenda: April, 26, 2012 (PDF - 35KB)Roster: April 26, 2012 (PDF - 6KB)FDA Executive Summary: April 26, 2012 (PDF - 618KB)Panel Questions: April 26, 2012 (PDF - 63KB)Voting Questions: April 26, 2012 (PDF - 18KB)24 Hour Summary: April 26, 2012 (PDF - 76KB)Transcript: April 26, 2012 (PDF - 876KB)
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April 26, 2012: Meeting Materials Non-FDA Generated
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