|Trade Name||CORDIS 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 |
Elimination of visual inspections for loose fibers inside the balloon that are conducted during the crimp and pack manufacturing process.