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Approval for expanding the indications for use. The device, as modified, will be marketed under the trade name celsius diagnostic/ablation deflectable tip catheter and is indicated as follows: the biosense webster celsius diagnostic/ablation deflectable tip catheter and related accessories are indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radiofrequency generators in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.
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