Food and Drug Administration
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)