DevicePMAs@therightstef:P110010_S001 / 89-95 JSONTXT

Approval for the promus element plus everolimus-eluting platinum chromium coronary stent system (monorail and over-the-wire). this device is indicated for improving luminal diameter in patients with symptomatic heart 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.

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PMA_MER 1 (1)