DevicePMAs@therightstef:P810046_S215 / 152-167
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Approval for the rx chassis 3 coronary dilation catheter. The device, as modified, 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, and 2) balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.
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