|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 PREMOUNTED STENT SYSTEMS|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice proposed a change in an in-process inspection step to remove the stent imprint as a rejection criterion for the elastomeric retaining sleeve component acceptance.