American College of Toxicology 31st Annual Meeting

The CYPHER® Sirolimus-eluting Stent was the first drug-eluting stent (DES) to receive regulatory approval in Europe (CE Mark 2002) and the US (PMA Approval 2003). During development and approval of CYPHER, no Guidance Documents were in place, and preclinical testing requirements for IDE and PMA approval were negotiated with the FDA. ................
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