DevicePMAs@therightstef:P030031_S025 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":27,"end":33},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T3","span":{"begin":52,"end":59},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25640"},{"id":"T4","span":{"begin":72,"end":78},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C821"},{"id":"T5","span":{"begin":79,"end":83},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41141"},{"id":"T6","span":{"begin":79,"end":88},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C82554"},{"id":"T7","span":{"begin":84,"end":88},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25636"},{"id":"T8","span":{"begin":110,"end":118},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25533"},{"id":"T9","span":{"begin":122,"end":128},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25337"},{"id":"T10","span":{"begin":180,"end":184},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25681"},{"id":"T11","span":{"begin":229,"end":237},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25285"},{"id":"T12","span":{"begin":242,"end":250},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25573"},{"id":"T13","span":{"begin":251,"end":254},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T14","span":{"begin":265,"end":273},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48187"},{"id":"T15","span":{"begin":284,"end":292},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C756"},{"id":"T16","span":{"begin":297,"end":304},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C95183"},{"id":"T17","span":{"begin":326,"end":334},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C756"},{"id":"T18","span":{"begin":344,"end":350},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25710"},{"id":"T19","span":{"begin":366,"end":375},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42770"},{"id":"T20","span":{"begin":412,"end":418},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T21","span":{"begin":423,"end":431},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25573"},{"id":"T22","span":{"begin":514,"end":522},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T23","span":{"begin":565,"end":573},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T24","span":{"begin":606,"end":614},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T25","span":{"begin":709,"end":712},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T26","span":{"begin":713,"end":721},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T27","span":{"begin":734,"end":743},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C112918"},{"id":"T28","span":{"begin":770,"end":778},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T29","span":{"begin":785,"end":792},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13306"},{"id":"T30","span":{"begin":814,"end":821},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C73942"},{"id":"T31","span":{"begin":872,"end":882},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T32","span":{"begin":886,"end":895},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42770"},{"id":"T33","span":{"begin":905,"end":914},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T34","span":{"begin":921,"end":925},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25284"},{"id":"T35","span":{"begin":928,"end":934},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T36","span":{"begin":928,"end":942},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51224"},{"id":"T37","span":{"begin":955,"end":958},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25150"},{"id":"T38","span":{"begin":984,"end":994},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38014"},{"id":"T39","span":{"begin":995,"end":1004},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14173"},{"id":"T40","span":{"begin":1005,"end":1016},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25269"},{"id":"T41","span":{"begin":1017,"end":1047},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C80391"},{"id":"T42","span":{"begin":1028,"end":1034},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T43","span":{"begin":1064,"end":1074},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T44","span":{"begin":1109,"end":1116},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C73942"},{"id":"T45","span":{"begin":1181,"end":1184},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T46","span":{"begin":1185,"end":1193},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T47","span":{"begin":1203,"end":1211},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25341"},{"id":"T48","span":{"begin":1212,"end":1223},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48191"},{"id":"T49","span":{"begin":1239,"end":1249},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T50","span":{"begin":1259,"end":1269},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C84954"},{"id":"T51","span":{"begin":1347,"end":1350},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C90069"},{"id":"T52","span":{"begin":1351,"end":1359},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17446"},{"id":"T53","span":{"begin":1401,"end":1404},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T54","span":{"begin":1423,"end":1430},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13306"},{"id":"T55","span":{"begin":1509,"end":1519},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C40414"},{"id":"T56","span":{"begin":1523,"end":1532},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42770"},{"id":"T57","span":{"begin":1554,"end":1558},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25284"},{"id":"T58","span":{"begin":1561,"end":1567},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37914"},{"id":"T59","span":{"begin":1561,"end":1575},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51224"},{"id":"T60","span":{"begin":1588,"end":1591},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25150"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T15","span":{"begin":959,"end":970},"obj":"age_range"},{"id":"T17","span":{"begin":959,"end":961},"obj":"age_start"},{"id":"T16","span":{"begin":965,"end":970},"obj":"age_end"},{"id":"T18","span":{"begin":1592,"end":1603},"obj":"age_range"},{"id":"T20","span":{"begin":1592,"end":1594},"obj":"age_start"},{"id":"T19","span":{"begin":1598,"end":1603},"obj":"age_end"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":959,"end":961},"obj":"age_start"},{"id":"T2","span":{"begin":965,"end":970},"obj":"age_end"},{"id":"T3","span":{"begin":959,"end":970},"obj":"age_range"},{"id":"T4","span":{"begin":1592,"end":1594},"obj":"age_start"},{"id":"T5","span":{"begin":1598,"end":1603},"obj":"age_end"},{"id":"T6","span":{"begin":1592,"end":1603},"obj":"age_range"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}

{"project":"PMA_age_indications","denotations":[{"id":"T17","span":{"begin":959,"end":961},"obj":"age_start"},{"id":"T15","span":{"begin":959,"end":970},"obj":"age_range"},{"id":"T16","span":{"begin":965,"end":970},"obj":"age_end"},{"id":"T20","span":{"begin":1592,"end":1594},"obj":"age_start"},{"id":"T18","span":{"begin":1592,"end":1603},"obj":"age_range"},{"id":"T19","span":{"begin":1598,"end":1603},"obj":"age_end"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":959,"end":961},"obj":"age_start"},{"id":"T2","span":{"begin":965,"end":970},"obj":"age_end"},{"id":"T3","span":{"begin":959,"end":970},"obj":"age_range"},{"id":"T4","span":{"begin":1592,"end":1594},"obj":"age_start"},{"id":"T5","span":{"begin":1598,"end":1603},"obj":"age_end"},{"id":"T6","span":{"begin":1592,"end":1603},"obj":"age_range"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}

{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T15","span":{"begin":959,"end":970},"obj":"age_range"},{"id":"T16","span":{"begin":965,"end":970},"obj":"age_end"},{"id":"T17","span":{"begin":959,"end":961},"obj":"age_start"},{"id":"T18","span":{"begin":1592,"end":1603},"obj":"age_range"},{"id":"T19","span":{"begin":1598,"end":1603},"obj":"age_end"},{"id":"T20","span":{"begin":1592,"end":1594},"obj":"age_start"}],"text":"Approval for the following device 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);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectionalthermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) 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 systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter andrelated accessories are indicated for use in catheter-based cardiac electrophysiologicalmapping (stimulating and recording) and, when used with a compatible rf generator, for thetreatment of type i atrial flutter in patients age 18 or older."}