|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||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a reduction of the internal diameter of the proximal shaft from 0. 0205" to 0. 0190" on the following premounted stent systems: noroyal(tm) advance, niroyal(tm) elite and nir(tm) elite.