|Trade Name||NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process by using scrapped material in the final functional testing for the sox(tm) component to minimize the amount of destroyed product at final testing.