|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||HERCULINK ELITE, RX|
|Classification Name||stent, renal|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reduce the number of samples used from each lot during pyrogen testing.