|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||BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|
|Classification Name||stent, carotid|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for replacing the partially encapsulated radiopaque markerband on the distal end of the retractable outer sheath in the stent delivery system with a fully encapsulated radiopaque markerband.