|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 SYSTEMS|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the indications for use statement and the instructions for use (ifu) to include the results of the nine-month follow-up of the nirvana clinical trial for the nir on ranger and nir primo premounted stent systems.