|Trade Name||FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Generic Name||coronary atherectomy catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the flexi-cut(tm) direction debulking system. The flexi-cut(tm) direction debulking system is indicated for use in coronary artery disease accessible to dca (directional coronary atherectomy), generally in the proximal or mid-portion of coronary vessels. It can be used alone or in conjunction with other coronary interventional devices. Dca is intended to improve coronary luminal diameter by mechanically shaving and removing atherosclerotic material from the diseased vessel.