DevicePMAs@therightstef:P960040_S031 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":32,"end":37},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T3","span":{"begin":56,"end":61},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T4","span":{"begin":84,"end":89},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T5","span":{"begin":170,"end":181},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60755"},{"id":"T6","span":{"begin":182,"end":187},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T7","span":{"begin":193,"end":200},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25714"},{"id":"T8","span":{"begin":265,"end":269},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T9","span":{"begin":285,"end":290},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T10","span":{"begin":309,"end":314},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T11","span":{"begin":337,"end":342},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T12","span":{"begin":423,"end":434},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60755"},{"id":"T13","span":{"begin":435,"end":440},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16866"},{"id":"T14","span":{"begin":446,"end":453},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25714"},{"id":"T15","span":{"begin":467,"end":477},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41184"},{"id":"T16","span":{"begin":482,"end":485},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T17","span":{"begin":530,"end":537},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C80514"},{"id":"T18","span":{"begin":564,"end":573},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T19","span":{"begin":577,"end":581},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C142142"},{"id":"T20","span":{"begin":577,"end":593},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C82508"},{"id":"T21","span":{"begin":594,"end":605},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T22","span":{"begin":619,"end":626},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16960"},{"id":"T23","span":{"begin":675,"end":682},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C74521"},{"id":"T24","span":{"begin":707,"end":718},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48307"},{"id":"T25","span":{"begin":753,"end":764},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T26","span":{"begin":798,"end":802},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25227"},{"id":"T27","span":{"begin":798,"end":807},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C102401"},{"id":"T28","span":{"begin":803,"end":807},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17102"},{"id":"T29","span":{"begin":861,"end":864},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T30","span":{"begin":865,"end":872},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25387"},{"id":"T31","span":{"begin":878,"end":890},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C95560"},{"id":"T32","span":{"begin":891,"end":900},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T33","span":{"begin":901,"end":904},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C45263"},{"id":"T34","span":{"begin":910,"end":915},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25629"},{"id":"T35","span":{"begin":916,"end":926},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25578"},{"id":"T36","span":{"begin":916,"end":937},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C27996"},{"id":"T37","span":{"begin":927,"end":937},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25738"},{"id":"T38","span":{"begin":954,"end":962},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25514"},{"id":"T39","span":{"begin":976,"end":983},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C165683"},{"id":"T40","span":{"begin":987,"end":995},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12380"}],"text":"Approval for the vitality ds vr model t135, vitality ds model t125, and vitality el model t127 implantable cardioverter defibrillator systems and the programmer software application model 2844 version 3.6. The device, as modified, will be marketed under the trade name vitality ds vr model t135, vitality ds model t125, and vitality el model t127 implantable cardioverter defibrillator systems and the programmer software application model 2844 version 3.6, and the indication for use is as follows: guidant icds are intended to provide therapy for the automated treatment of life threatening ventricular arrhythmias. patient populations who are indicated for a guidant icd include 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction of \u003c=30% (as defined in appendix e )."}