DevicePMAs@therightstef:P110010_S096 JSONTXT

Approval for the promus element plus and promus premier everolimus-eluting platinum chromiumcoronary stent systems (monorail and over-the-wire). these devices are indicated forimproving luminal diameter in patients, including those with diabetes mellitus, with symptomaticheart disease or documented silent ischemia due to de novo lesions in native coronary arteries>=2.25 mm to <=4.00 mm in diameter in lesions <=34 mm in length.