DevicePMAs@therightstef:P990071_S013 JSON TXT

Annnotations TAB JSON ListView MergeView

PMA_MER

updated_tagging_age_PMA_annotations

{"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"}],"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."}

PMA_age_indications

{"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"}],"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."}

consensus_PMA_Age_Indications

{"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"}],"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."}

Age_blah

{"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"}],"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."}