|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CYPHER SIROLIMUS-ELUTING CORONARY STENT|
|Classification Name||coronary drug-eluting stent|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a "tip rounding" step to the crimp and pack unit manufacturing operation and update of the visual quality standard requirements for the catheter distal tip.