|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||NIR(R) PREMOUNTED STENT SYSTEM|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the acceptance criteria for an in-process inspection step for the balloon component used in the manufacture of the nir(r) premounted stent systems.