|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||EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|
|Classification Name||stent, renal|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to manufacture the flushing needle (also known as tip barrell 30 gauge) accessory with an alternative resin provided by a new supplier.