|Trade Name||CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|
|Classification Name||coronary drug-eluting stent|
|Generic Name||drug eluting stent|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a second identity method for rapamycin in cypher sirolimus-eluting coronary stents. This method will be performed in conjunction with the currently approved identity method. The addition of the second identity method is in accordance with one of the conditions of approval commitments made for this pma.