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FDA > CDRH > Information on Premarket Approval Applications > CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR® Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System - P020026

CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR® Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System - P020026

Issued 4/24/03

• Part 1 - Approval Order
• Part 2 - Summary of Safety and Effectiveness
• Part 3 - Labeling for Professionals
• Part 4 - Labeling for Patients
• Other Consumer Information

This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document.

Updated September 8, 2004

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Center for Devices and Radiological Health / CDRH