|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 DELIVERY SYSTEMS|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the alternate manufacturing facilities for packaging and labeling located at boston scientific corporation, quincy massachusetts and boson scientific european distribution center, beek, the netherlands.