|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(R) PREMOUNTED 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 |
Change from an internal particulate maximum level to an internal particulate action level of 75,000 particles >=10 microns for the finished product.