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DevicePMAs@therightstef:P810046_S198 JSONTXT 11 Projects

The device is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.

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