|Trade Name||RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|
|Classification Name||stent, carotid|
|Generic Name||stent, carotid|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to a manufacturing process to improve wicking of glue between the hypotube and the inner member and a modification to the lot history record bill of materials to add a new block for documenting the new process.