|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||PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS|
|Classification Name||stent, carotid|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in colorant used in the catheters of the precise and smart nitinol stent systems.