DevicePMAs@therightstef:P150005_S014 JSONTXT 13 Projects

Approval for the Blazer and IntellaNav Open-Irrigated Ablation Catheters. The Blazer and IntellaNav Open-Irrigated Ablation Catheters, when used with a compatible Radiofrequency Controller and Irrigation Pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation of sustain or recurrent Type 1 Atrial Flutter in patients age 18 or older, and treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system.