|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||SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM|
|Classification Name||stent, iliac|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - color additive|
|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.