|Trade Name||CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES|
|Classification Name||stent, coronary|
|Generic Name||coronary stent and delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market a new stent system. The device is indicated for improving coronary luminal diameter in the following: patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length < 30 mm) with a reference vessel diameter of 3. 0 to 4. 0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present.