2016 Meeting Materials of the Circulatory System Devices Panel
June 2-3, 2016: Meeting Materials FDA Generated
- Agenda: June 2, 2016
- Agenda: June 3, 2016
- Roster: June 2-3, 2016
- Panel Questions: June 2-3, 2016
- FDA Executive Summary: June 2-3, 2016
- FDA Presentation: June 2-3, 2016
- 24 Hour Summary: June 2-3, 2016
- Transcript: June 2, 2016
- Transcript: June 3, 2016
June 2-3, 2016: Meeting Materials Non-FDA Generated
- Presentation: Joseph O. Falkinham, III
- Presentation: CSZ
- Presentation: Hugo Sax, MD
- Presentation: Joseph Perz, DrPH MA
- Presentation: CardioQuip
- Presentation: Jeffrey R. Miller, MD, MPH
- Presentation: LivaNova
- Presentation: L. Silvia Munoz-Price, M.D., Ph.D.
- Presentation: Charles L. Daley, MD
- Presentation: Michael Strong, Ph.D.
- Presentation: Daniel Diekema
May 24, 2016: Meeting Materials FDA Generated
- Waiver: Richard L. Page, M.D.
- Acknowledgment of Financial Interests: Richard L. Page, M.D.
- Agenda: May 24, 2016
- Roster: May 24, 2016
- Panel Questions: May 24, 2016
- FDA Executive Summary: May 24, 2016
- 24 Hour Summary: May 24, 2016
- FDA Presentation: May 24, 2016
- Transcript: May 24, 2016
May 24, 2016: Meeting Materials Non-FDA Generated
- Table of Contents: May 24, 2016
- Sponsor Executive Summary: May 24, 2016
- Proposed SSED (Summary of Safety and Effectiveness Data): May 24, 2016
- Instructions for Use: May 24, 2016
- Patient Guide: May 24, 2016
- Proposed Post-Approval Study: May 24, 2016
- St. Jude Presentation: May 24, 2016
March 16, 2016: Meeting Materials FDA Generated
- Agenda: March 16, 2016
- Roster: March 16, 2016
- Panel Questions: March 16, 2016
- Voting Questions: March 16, 2016
- FDA Executive Summary: March 16, 2016
- FDA Presentation: March 16, 2016
- 24 Hour Summary: March 16, 2016
- Transcript: March 16, 2016
March 16, 2016: Meeting Materials Non-FDA Generated
- Sponsor Executive Summary: March 16, 2016
- SSED: March 16, 2016
- Package Insert: March 16, 2016
- Patient Labeling: March 16, 2016
- Post Market Registry Study Proposal: March 16, 2016
- Proposed Package Inserts: March 16, 2016
- Proposed Patient Labeling: March 16, 2016
- Reference List: March 16, 2016
- Sponsor Presentation: March 16, 2016
- Testimonies: March 16, 2016
March 15, 2016: Meeting Materials FDA Generated
- Agenda: March 15, 2016
- Roster: March 15, 2016
- Panel Questions: March 15, 2016
- Voting Questions: March 15, 2016
- FDA Executive Summary: March 15, 2016
- FDA Presentation: March 15, 2016
- 24 Hour Summary: March 15, 2016
- Transcript: March 15, 2016
March 15, 2016: Meeting Materials Non-FDA Generated
- Table of Contents: March 15, 2016
- Sponsor Executive Summary: March 15, 2016
- Proposed SSED: March 15, 2016
- Proposed Instructions for Use: March 15, 2016
- Appendix I: March 15, 2016
- Appendix II: March 15, 2016
- Appendix III: March 15, 2016
- Sponsor Presentation: March 15, 2016
February 18, 2016: Meeting Materials FDA Generated
- Agenda: Feb. 18, 2016
- Roster: Feb. 18, 2016
- Panel Questions: Feb. 18, 2016
- FDA Executive Summary and Questions: Feb. 18, 2016
- FDA Presentation: Feb. 18, 2016
- 24 Hour Summary: Feb. 18, 2016
- Transcript: Feb. 18, 2016
February 18, 2016: Meeting Materials Non-FDA Generated
- Micra Panel Pack
- Nanostim Panel Pack
- AHA Statement to FDA on Leadless Cardiac Pacemaker Devices
- Presentation: St. Jude Medical
- Presentation : Medtronic
- Presentation: Boston Scientific