|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 MONORAIL PREMOUNTED STENT SYSTEM|
|Classification Name||stent, renal|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for reinstatement of a secondary sterilization site formerly owned by steris isomedix services, inc. (steris) located in coventry, rhode island.