Food and Drug Administration

Circulatory System Devices Panel

July 28, 2004

Briefing Information

Summary of Safety and Effectiveness (PDF)

Contak Renewal® 3 and Contak Renewal® 3 HE System Guide, Guidant Corp (PDF)

Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) (PDF)

Expanded Indications and Claims for Guidant CRT-D Devices, Dr. Owen Faris, PhD, FDA (PPT)

Clinical Review, Dr. Scott Proestel, MD, FDA (HTM) (Word)

Statistical Review, Barbara Krasnicka, PhD, FDA (HTM) (PDF) (Word)