DevicePMAs@therightstef:P810046_S203 11 Projects
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Approval for the rx chassis 1(tm) coronary dilatation catheter. The device, as modified, is indicated for a) balloon dilatation of the stenotic portion of a coronary artery of bypass graft stenosis for the purpose of improving myocardial perfusion, and b) 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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