DevicePMAs@therightstef:P030031_S072 JSONTXT 11 Projects

Approval for the THERMOCOOL SMARTTOUCH SF Catheters, part numbers D-1347-XX-S and D-1348-XX-S, 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 paroxysmalatrial fibrillation, when used with compatible three dimensional electroanatomic mapping systems. The THERMOCOOL SMARTTOUCH SF Navigation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO 3 Navigation System.