|Trade Name||S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the medtronic ave s660 2. 75 with discrete technology over-the-wire coronary stent system. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (<=24 mm in length) in native coronary artery or arterial bypass graft conduit with a reference diameter between 2. 2 mm and 2. 9 mm. Long-term outcome (beyond 30 days) for this implant is unknown at present.