|Trade Name||NIR STENT DELIVERY SYSTEMS|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternative manufacturing process to produce balloons for nir(r) and niroyal(r) stent delivery systems. The alternative process affects only the method of stretching the balloon tubing prior to molding the balloon.