|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||RX HERCULINK ELITE RENAL STENT SYSTEM|
|Classification Name||stent, renal|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of receiving inspection capabilities at the clonmel, ireland manufacturing site and contract laboratories.