DevicePMAs@therightstef:P160043_S012 / 278-284
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Approval for the Resolute Onyx Zotarolimus-Eluting Coronary Stent System. The device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length <= 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm. In addition, the Resolute Onyx Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions.
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