|Trade Name||CYPHER SIROLIMUS ELUTING CORONARY STENT|
|Classification Name||coronary drug-eluting stent|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of cypher otw stents for analytical testing performed prior to release into finished goods inventory and for the reserve samples for both the cypher sirolimus-eluting coronary stent rapid exchange (rx) and over-the-wire (otw) delivery systems.