Food and Drug Administration

Circulatory System Devices Panel

October 22, 2002

Briefing Information

P020026, CYPHER™ Sirolimus-Eluting Coronary Stent System

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Summary of Safety and Effectiveness Based on PMA  (PDF) (Word)

Understanding Coronary Artery Disease, Cardiac Catheterization, and Treatment Options, A Guide for Patients  (PDF) (Word)