DevicePMAs@therightstef:P030031_S025 JSONTXT 13 Projects

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.