|Trade Name||CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)|
|Classification Name||coronary drug-eluting stent|
|Generic Name||drug eluting stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the 4. 0mm cypher sirolimus-eluting coronary stent on raptorrail (rx) delivery system. The device, as modified will be marketed under the trade name 4. 00mm cypher sirolimus-eluting coronary stent on raptorrail rapid exchange delivery system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30 mm in native coronary arteries with a reference vessel diameter of >= 2. 25 to <= 4. 0 mm.