DevicePMAs@therightstef:P030009_S039 / 0-5 JSONTXT

Approval for the integrity coronary stent system. the device is indicated for improvingcoronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions, with reference vessel diameters of 2.25-4.0 mm and <=30 mm in length, using direct stenting or predilatation.

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