Food and Drug Administration

Circulatory System Devices Panel

October 22, 2002



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.

Cypher™ Sirolimus-Eluting Stent PMA# P020026, Dr. Dennis Donohoe, MD, Therapeutics and Clinical Research  (PDF)

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Cypher™ Sirolimus-Eluting Coronary Stent System, FDA Summary (HTM) (PPT)