|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||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Add two additional individual molding station (ims) balloon molding towers in the balloons production area at the maple grove facility.