|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 SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|
|Classification Name||stent, iliac|
|Generic Name||iliac stent|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a self contained biological indicator in place of a spore strip biological indicator).