|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||S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|
|Classification Name||stent, iliac|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the material composition of the tubing in the hemostasis valve.