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DevicePMAs@therightstef:P100023_S053 JSONTXT

Approval for removal of the ball from the tip of the corewire which islocated between the inner and outer lumen of the stent delivery system. the device, as modified, will be marketed under the trade promus element plus everolimus-eluting platinum chromium coronary stent system and ion paclitaxel-eluting platinum chromiumcoronary stent system and are 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, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 mm to >4.00 mm in diameter in lesions <34 mm in length, respectively

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