|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 CONTROL VASCULAR STENT SYSTEMS|
|Classification Name||stent, superficial femoral artery|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of a new ultrasonic welder to be used by the supplier of the hemostasis valve of the slider assembly.