DevicePMAs@therightstef:P860019_S149 JSONTXT

{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":41,"end":49},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41072"},{"id":"T3","span":{"begin":78,"end":86},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T4","span":{"begin":94,"end":100},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T5","span":{"begin":170,"end":178},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41072"},{"id":"T6","span":{"begin":170,"end":185},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12843"},{"id":"T7","span":{"begin":179,"end":185},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12372"},{"id":"T8","span":{"begin":189,"end":195},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15723"},{"id":"T9","span":{"begin":196,"end":201},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12981"},{"id":"T10","span":{"begin":202,"end":210},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50754"},{"id":"T11","span":{"begin":219,"end":226},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25634"},{"id":"T12","span":{"begin":240,"end":250},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25578"},{"id":"T13","span":{"begin":251,"end":260},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C150246"},{"id":"T14","span":{"begin":466,"end":474},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"}],"text":"Approval requested for the SCIMED REMEDY Coronary Balloon Dilatation Infusion Catheter . The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion , and to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atm. The REMEDY catheter (2.5 - 4.0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents."}