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Dockets Management

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Food and Drug Administration

Circulatory System Devices Panel

September 19 & 20, 2007

REPEL-CV Bioresorbable Adhesion Barrier Film
P070005

SLIDES

2007-4318s1-01 – FDA Review of P070005 (pdf)

2007-4318s1-02 – FDA – Power to detect a difference (pdf)

2007-4318s2-04 – FDA – Presentation, General Issue: Clinical Trial Designs for Atrial Fibrillation Treatment Devices (pdf)

OPH

2007-4318oph2-01 - Biosense Webster : Presentation to FDA Circulatory Systems Advisory Panel September 20, 2007; Albert Waldo, MD (pdf)

2007-4318oph2-02 - CryoCath Technologies Presentation by Jean-Pierre Desmarais (pdf)

2007-4318oph2-03 - CryoCor Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation ICE-PAF Study; Helen Barold, MD (pdf)
 
2007-4318oph2-04 - ProRhythm: HIFU Ablation for the Treatment of AF  Clinical Trial Experience; Hugh Calkins, MD (pdf)

2007-4318oph2-05 - ACC/AHA/ESC 2006 Atrial Fibrillation Management Guidelines; Eric Prystowsky, MD (pdf)

2007-4318oph2-06 -HRS / EHRA / ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation; Douglas Packer, MD, FERS (pdf)

2007-4318oph2-07 - American Heart Association: Clinical Trial Designs for Cardiac Ablation Devices for Atrial Fibrillation; Mark Estes (pdf)

2007-4318oph2-08 - Society of Thoracic Surgeons: Surgical AF Treatment: Surgical Trials; Patrick McCarthy M.D. (pdf)

2007-4318oph2-09- Inova Heart: Surgical Ablation of Atrial Fibrillation; Niv Ad, MD (pdf)

2007-4318oph2-10 -AdvaMed Comments by Ruey C. Dempsey (pdf)

2007-4318oph2-11 - Improving Outcome Assessment in AF Ablation Trials a Core Lab Perspective; Alexei Shvilkin, MD (pdf)

2007-4318oph2-12 - CardioFocus Statement by Burke T. Barrett (pdf)

2007-4318oph2-13 - ProRhythm focus AF Clinical Investigation Clinical Trial Synopsis, Enrollment Status and Current Challenges Panel Synopsis Statement (pdf)

2007-4318oph2-14 - Dr. Blackstone's Slides on Atrial Fibrillation (pdf)

2007-4318oph2-15 - Dr. Blackstone's Comments as Primary Reviewer for the Circulatory System Devices Panel (pdf)


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