|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 PRIMO PREMOUNTED STENT DELIVERY SYSTEM|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the nir(tm) primo(tm) premounted stent delivery system.