Food and Drug Administration

CIRULATORY SYSTEM DEVICES PANEL
Of the
MEDICAL DEVICES ADVISORY COMMITTEE

NAVISTAR® THERMOCOOL® Catheter
for the Radiofrequency Ablation
of Symptomatic Paroxysmal
Atrial Fibrillation
PMA # P030031/S11

November 20, 2008

SLIDES

FDA Presentations:

FDA Presentation (pdf)
      Presented by:

• Benjamin C. Eloff Ph.D., Biomedical Engineer, Cardiac Electrophysiology and Monitoring Branch, Division of Cardiovascular Devices, Office of Device Evaluation

• Laura Thompson Ph.D. Division of Biostatistics, Office of Surveillance and Biometrics
• Randall Brockman M.D., Medical Officer, Cardiac Electrophysiology and Monitoring Branch, Division of Cardiovascular Devices, Office of Device Evaluation
• Ellen Pinnow, M.S., Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics

FDA Panel Questions (pdf)
            Presented by:

• Benjamin C. Eloff Ph.D., Biomedical Engineer, Cardiac Electrophysiology and Monitoring Branch, Division of Cardiovascular Devices, Office of Device Evaluation

Sponsor Presentations:

Sponsor Presentation (pdf)
      Presented by:

• Marcia S. Yaross, Ph.D., Vice President, Clinical, Regulatory, and Health Policy, Biosense Webster, Inc.
• Donald A. Berry, Ph.D. Statistical Consultant, Berry Consultants, Chairman, Department of Biostatistics $ Frank T. McGraw Memorial Chair of Cancer Research, The University of Texas M.D. Anderson Cancer Center
• David J. Wilber, M.D., FAHA, FACC, Primary Investigator, George M. Eisenberg Professor of Cardiovascular Sciences; Cardiovascular Sciences; Director, Division of Cardiology; Loyola University Medical Center (Maywood, IL)
• Albert L. Waldo, M.D., FACC, FAHA, FHRS; The Walter H. Pritchard Professor of Cardiology, Professor of Medicine & Professor Biomedical Engineering; Case Western Reserve University, Associate Chief of Cardiology for Academic Affairs, University Hospitals Case Medical Center, Cleveland, OH
• Marcia S. Yaross, Ph.D., Vice President, Clinical, Regulatory, and Health Policy, Biosense Webster, Inc.

Primary Reviewer Slides (pdf)
Presented by:

David J. Slotwiner M.D., Associate Director, Electrophysiology Laboratory, Long Island Jewish Medical Center, NewHyde Park. NY

---

Top | Up | AC Home Page