|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||ZILVER VASCULAR STENT|
|Classification Name||stent, iliac|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at cook ireland, ltd. , limerick, ireland for manufacturing and final manufacturing to include labeling and packaging, and for a sterilization site located at isotron ireland, ltd. , tullamore, ireland.