|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 SYSTEM|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the specification of the balloon component for the nir(tm) primo(tm) premounted stent system. This change applies only to the 9 mm length nir(tm) primo(tm) premounted stent system with the 3. 0 mm, 3. 5 mm, and 4. 0 mm balloon diameters.