DevicePMAs@therightstef:P030025_S086 / 369-376 JSONTXT

Approval to expand the labeled indications for the taxus express2 paclitaxel-eluting coronary stent system. The taxus express2 paclitaxel-eluting coronary stent system is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions<= 28 mm in length; 2) 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; or 3) within bare metal stent restenotic lesions 2.50 mm to 3.75 mm in diameter and <= 28 mm in length.

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PMA_MER 1 (1)