|Trade Name||CYPHER SIROLIMUS-ELUTING CORONARY STENTS|
|Classification Name||coronary drug-eluting stent|
|Generic Name||drug-eluting stent|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change of the transfer of stent trays during the spray coating unit operation from the current methodology to a continuous manner from the coating step to another.