|Trade Name||FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Generic Name||catheter, coronary, atherectomy|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes for the flexi-cut(tm) directional debulking system. The labeling changes include the addition of a summary of the physician preference testing information, and the addition of a warning statement to remove atheromatous tissue from the nosecone frequently to avoid guidewire restriction.