|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 ON RANGER PREMOUNTED STENT SYSTEMS|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the postapproval study protocol for the nir on(tm) ranger w/sox(tm) and nir on(tm) ranger(tm) premounted stent systems.