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Approval for the Chili(R) Cooled Ablation System which includes: 1)Chili(R) Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chili(R) Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chili(R) Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.
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