|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.|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternate sterilization facility located at sterigenics international, inc. , gurnee, illinois.