DevicePMAs@therightstef:P960016_S009 JSONTXT 11 Projects

Approval for revised indications for use for these models of livewire tc ablation catheters: 5mm livewire tc steerable electrophysiology catheters xls with universal sensor (models 402205-402208); 5mm livewire tc steerable electrophysiology catheters xls with thermistor (models 402209-402212); 5mm livewire tc steerable electrophysiology catheters xls with thermocouple (models 402213-402216); 4mm livewire tc steerable electrophysiology cathether with thermistor (models 402229-402232); and 4mm livewire tc steerable electrophysiology catheter xls with thermistor (models 402233-402236). The catheters are indicated for cardiac electrophysiological mapping and for use with a compatible rf generator for creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.