DevicePMAs@therightstef:P900061_S047 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":135,"end":139},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T3","span":{"begin":189,"end":192},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T4","span":{"begin":216,"end":220},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17102"},{"id":"T5","span":{"begin":224,"end":236},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C107103"},{"id":"T6","span":{"begin":237,"end":240},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45263"},{"id":"T7","span":{"begin":244,"end":255},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T8","span":{"begin":289,"end":292},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C66832"},{"id":"T9","span":{"begin":326,"end":334},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17177"},{"id":"T10","span":{"begin":347,"end":350},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C66832"},{"id":"T11","span":{"begin":351,"end":358},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C75539"},{"id":"T12","span":{"begin":364,"end":371},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13306"},{"id":"T13","span":{"begin":364,"end":378},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50479"},{"id":"T14","span":{"begin":372,"end":378},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61462"},{"id":"T15","span":{"begin":394,"end":398},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25559"},{"id":"T16","span":{"begin":402,"end":415},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37929"},{"id":"T17","span":{"begin":417,"end":420},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45263"},{"id":"T18","span":{"begin":426,"end":437},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T19","span":{"begin":438,"end":453},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C110938"},{"id":"T20","span":{"begin":497,"end":508},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"}],"text":"Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name gem vr models 7227 b/d/e/cx and is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of a cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated, sustained ventricular tachycardia."}