DevicePMAs@therightstef:P060008_S046 JSONTXT 11 Projects

Approval to expand the labeled indications for the taxus libert paclitaxel-eluting coronary stent system. The taxus libert paclitaxel-eluting coronary stent system (monorail and over-the-wire systems) is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.75 mm to 4.00 mm in diameter in lesions <= 34 mm in length; 2) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 2.50 mm in diameter in lesions <= 28 mm in length; or 3) in patients undergoing primary angioplasty to treat acute st-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and < 12 hours in duration.