|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||SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|
|Classification Name||stent, iliac|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - performance characteristics|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to incorporate an additional precaution into the instructions for use to address the potential for stent fractures that may occur with self-expanding stents such as the cordis smart stent systems.