Food and Drug Administration

Circulatory System Devices Panel

April 22, 2005

Briefing Information

FDA Slide Presentation - PAS-Port Proximal Anastomosis System by Cardica, Inc., Kachi Enyinna, MS, Dr. Barbara Krasnicka, PhD, & Dr. Wolf Sapirstein, MD (HTM) (PPT)

Clinical Review, Dr. Wolf Sapirstein, MD, FDA (HTM) (PPT)

Summary of Safety and Effectiveness Data (HTM) (PDF) (Word)

Cardica® PAS-Port® Proximal Anastomosis System, Instructions for Use (HTM) (PDF) (Word)

Statistical Review, Dr. Barbara Krasnicka, PhD, FDA (HTM) (PPT)