Food and Drug Administration

Circulatory Systems Panel

September 10, 2002

Briefing Information

Summary of Safety and Effectiveness  doc   pdf

The CardioSEAL^® STARFlex™ Septal Occlusion System With Qwik Load Instructions For Use for Transcatheter PFO Closure  doc   pdf

P000049/S3 Panel Questions For Discussion  doc   pdf

  Lead Reviewer & Engineering, Clinical, and Statistical Summaries, FDA   doc   pdf

FDA Summary   ppt