|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(TM) PREMOUNTED STENT SYSTEMS|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested to increase the tolerance allowed in the stent overlap to markerband placement by 0. 25 mm (from 0. 25mm to 0. 50mm).