DevicePMAs@therightstef:P990071_S013 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P990071_S013","sourcedb":"DevicePMAs@therightstef","sourceid":"P990071_S013","text":"Approval for the following modifications: 1) reduced recommended saline flow rate (reduce by ~50%; 2) increase in number of irrigation holes (from 6 to 56); 3) decrease in size of irrigation holes (from 0.016 to 0.0035 diameter); and 4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum).the device, as modified will be marketed under the trade names uni-directional carto xp thermocool sf nav catheter, uni-directional carto 3 thermocool sf nav catheter, and uni-directional thermocool sf catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rt generator, for the treatment of: a) type i atrial flutter in patients age 18 or older; b) drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The thermocool sf nav diagnostic/ablation deflectable tip catheter provides location information when used with compatible carto ep navigation ssytems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of type i atrial flutter in patients age 18 or older.","tracks":[{"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":45,"end":52},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25640"},{"id":"T3","span":{"begin":65,"end":71},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C821"},{"id":"T4","span":{"begin":72,"end":76},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41141"},{"id":"T5","span":{"begin":72,"end":81},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C82554"},{"id":"T6","span":{"begin":77,"end":81},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25636"},{"id":"T7","span":{"begin":102,"end":110},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25533"},{"id":"T8","span":{"begin":114,"end":120},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25337"},{"id":"T9","span":{"begin":172,"end":176},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25681"},{"id":"T10","span":{"begin":219,"end":227},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25285"},{"id":"T11","span":{"begin":237,"end":245},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25573"},{"id":"T12","span":{"begin":246,"end":249},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T13","span":{"begin":260,"end":268},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48187"},{"id":"T14","span":{"begin":279,"end":287},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C756"},{"id":"T15","span":{"begin":292,"end":299},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C95183"},{"id":"T16","span":{"begin":321,"end":329},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C756"},{"id":"T17","span":{"begin":346,"end":354},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25573"},{"id":"T18","span":{"begin":437,"end":445},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T19","span":{"begin":489,"end":497},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T20","span":{"begin":533,"end":541},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T21","span":{"begin":563,"end":571},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T22","span":{"begin":578,"end":585},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13306"},{"id":"T23","span":{"begin":607,"end":614},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C73942"},{"id":"T24","span":{"begin":665,"end":675},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T25","span":{"begin":698,"end":707},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T26","span":{"begin":715,"end":719},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25284"},{"id":"T27","span":{"begin":722,"end":728},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T28","span":{"begin":722,"end":736},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51224"},{"id":"T29","span":{"begin":749,"end":752},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25150"},{"id":"T30","span":{"begin":774,"end":784},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38014"},{"id":"T31","span":{"begin":785,"end":794},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14173"},{"id":"T32","span":{"begin":795,"end":806},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25269"},{"id":"T33","span":{"begin":807,"end":837},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C80391"},{"id":"T34","span":{"begin":818,"end":824},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T35","span":{"begin":854,"end":864},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T36","span":{"begin":899,"end":906},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C73942"},{"id":"T37","span":{"begin":971,"end":974},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T38","span":{"begin":975,"end":983},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T39","span":{"begin":993,"end":1001},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25341"},{"id":"T40","span":{"begin":1002,"end":1013},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T41","span":{"begin":1029,"end":1039},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T42","span":{"begin":1049,"end":1059},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C84954"},{"id":"T43","span":{"begin":1137,"end":1140},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T44","span":{"begin":1141,"end":1149},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T45","span":{"begin":1192,"end":1195},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T46","span":{"begin":1214,"end":1221},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13306"},{"id":"T47","span":{"begin":1243,"end":1250},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C73942"},{"id":"T48","span":{"begin":1301,"end":1311},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T49","span":{"begin":1334,"end":1343},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T50","span":{"begin":1347,"end":1351},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25284"},{"id":"T51","span":{"begin":1354,"end":1360},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T52","span":{"begin":1354,"end":1368},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51224"},{"id":"T53","span":{"begin":1381,"end":1384},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25150"}],"attributes":[{"subj":"T1","pred":"source","obj":"PMA_MER"},{"subj":"T2","pred":"source","obj":"PMA_MER"},{"subj":"T3","pred":"source","obj":"PMA_MER"},{"subj":"T4","pred":"source","obj":"PMA_MER"},{"subj":"T5","pred":"source","obj":"PMA_MER"},{"subj":"T6","pred":"source","obj":"PMA_MER"},{"subj":"T7","pred":"source","obj":"PMA_MER"},{"subj":"T8","pred":"source","obj":"PMA_MER"},{"subj":"T9","pred":"source","obj":"PMA_MER"},{"subj":"T10","pred":"source","obj":"PMA_MER"},{"subj":"T11","pred":"source","obj":"PMA_MER"},{"subj":"T12","pred":"source","obj":"PMA_MER"},{"subj":"T13","pred":"source","obj":"PMA_MER"},{"subj":"T14","pred":"source","obj":"PMA_MER"},{"subj":"T15","pred":"source","obj":"PMA_MER"},{"subj":"T16","pred":"source","obj":"PMA_MER"},{"subj":"T17","pred":"source","obj":"PMA_MER"},{"subj":"T18","pred":"source","obj":"PMA_MER"},{"subj":"T19","pred":"source","obj":"PMA_MER"},{"subj":"T20","pred":"source","obj":"PMA_MER"},{"subj":"T21","pred":"source","obj":"PMA_MER"},{"subj":"T22","pred":"source","obj":"PMA_MER"},{"subj":"T23","pred":"source","obj":"PMA_MER"},{"subj":"T24","pred":"source","obj":"PMA_MER"},{"subj":"T25","pred":"source","obj":"PMA_MER"},{"subj":"T26","pred":"source","obj":"PMA_MER"},{"subj":"T27","pred":"source","obj":"PMA_MER"},{"subj":"T28","pred":"source","obj":"PMA_MER"},{"subj":"T29","pred":"source","obj":"PMA_MER"},{"subj":"T30","pred":"source","obj":"PMA_MER"},{"subj":"T31","pred":"source","obj":"PMA_MER"},{"subj":"T32","pred":"source","obj":"PMA_MER"},{"subj":"T33","pred":"source","obj":"PMA_MER"},{"subj":"T34","pred":"source","obj":"PMA_MER"},{"subj":"T35","pred":"source","obj":"PMA_MER"},{"subj":"T36","pred":"source","obj":"PMA_MER"},{"subj":"T37","pred":"source","obj":"PMA_MER"},{"subj":"T38","pred":"source","obj":"PMA_MER"},{"subj":"T39","pred":"source","obj":"PMA_MER"},{"subj":"T40","pred":"source","obj":"PMA_MER"},{"subj":"T41","pred":"source","obj":"PMA_MER"},{"subj":"T42","pred":"source","obj":"PMA_MER"},{"subj":"T43","pred":"source","obj":"PMA_MER"},{"subj":"T44","pred":"source","obj":"PMA_MER"},{"subj":"T45","pred":"source","obj":"PMA_MER"},{"subj":"T46","pred":"source","obj":"PMA_MER"},{"subj":"T47","pred":"source","obj":"PMA_MER"},{"subj":"T48","pred":"source","obj":"PMA_MER"},{"subj":"T49","pred":"source","obj":"PMA_MER"},{"subj":"T50","pred":"source","obj":"PMA_MER"},{"subj":"T51","pred":"source","obj":"PMA_MER"},{"subj":"T52","pred":"source","obj":"PMA_MER"},{"subj":"T53","pred":"source","obj":"PMA_MER"}]},{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":753,"end":755},"obj":"age_start"},{"id":"T2","span":{"begin":759,"end":764},"obj":"age_end"},{"id":"T3","span":{"begin":1385,"end":1387},"obj":"age_start"},{"id":"T4","span":{"begin":1391,"end":1396},"obj":"age_end"},{"id":"T5","span":{"begin":753,"end":764},"obj":"age_range"},{"id":"T6","span":{"begin":1385,"end":1396},"obj":"age_range"}],"attributes":[{"subj":"T1","pred":"source","obj":"Age_blah"},{"subj":"T2","pred":"source","obj":"Age_blah"},{"subj":"T3","pred":"source","obj":"Age_blah"},{"subj":"T4","pred":"source","obj":"Age_blah"},{"subj":"T5","pred":"source","obj":"Age_blah"},{"subj":"T6","pred":"source","obj":"Age_blah"}]},{"project":"PMA_age_indications","denotations":[{"id":"T8","span":{"begin":753,"end":764},"obj":"age_range"},{"id":"T10","span":{"begin":753,"end":755},"obj":"age_start"},{"id":"T9","span":{"begin":759,"end":764},"obj":"age_end"},{"id":"T13","span":{"begin":1385,"end":1387},"obj":"age_start"},{"id":"T11","span":{"begin":1385,"end":1396},"obj":"age_range"},{"id":"T12","span":{"begin":1391,"end":1396},"obj":"age_end"}],"attributes":[{"subj":"T8","pred":"source","obj":"PMA_age_indications"},{"subj":"T10","pred":"source","obj":"PMA_age_indications"},{"subj":"T9","pred":"source","obj":"PMA_age_indications"},{"subj":"T13","pred":"source","obj":"PMA_age_indications"},{"subj":"T11","pred":"source","obj":"PMA_age_indications"},{"subj":"T12","pred":"source","obj":"PMA_age_indications"}]},{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T10","span":{"begin":753,"end":755},"obj":"age_start"},{"id":"T11","span":{"begin":1385,"end":1396},"obj":"age_range"},{"id":"T12","span":{"begin":1391,"end":1396},"obj":"age_end"},{"id":"T13","span":{"begin":1385,"end":1387},"obj":"age_start"},{"id":"T8","span":{"begin":753,"end":764},"obj":"age_range"},{"id":"T9","span":{"begin":759,"end":764},"obj":"age_end"}],"attributes":[{"subj":"T10","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T11","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T12","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T13","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T8","pred":"source","obj":"updated_tagging_age_PMA_annotations"},{"subj":"T9","pred":"source","obj":"updated_tagging_age_PMA_annotations"}]},{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T10","span":{"begin":753,"end":755},"obj":"age_start"},{"id":"T8","span":{"begin":753,"end":764},"obj":"age_range"},{"id":"T9","span":{"begin":759,"end":764},"obj":"age_end"},{"id":"T11","span":{"begin":1385,"end":1396},"obj":"age_range"},{"id":"T13","span":{"begin":1385,"end":1387},"obj":"age_start"},{"id":"T12","span":{"begin":1391,"end":1396},"obj":"age_end"}],"attributes":[{"subj":"T10","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T8","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T9","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T11","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T13","pred":"source","obj":"consensus_PMA_Age_Indications"},{"subj":"T12","pred":"source","obj":"consensus_PMA_Age_Indications"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"PMA_MER","color":"#e2ec93","default":true},{"id":"Age_blah","color":"#dc93ec"},{"id":"PMA_age_indications","color":"#93ecc2"},{"id":"updated_tagging_age_PMA_annotations","color":"#eca793"},{"id":"consensus_PMA_Age_Indications","color":"#9398ec"}]}]}}