|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||NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use of a new stent cleaning rack during the final cleaning process in the manufacture of the device.