|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||NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEM|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the 4. 5 and 5. 0 mm diameter niroyal(tm) advance premounted stent systems.