The Thermedical® Ablation System is 510(k) cleared for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.  Use of the Thermedical Ablation System for any specific soft tissue indication has not been evaluated or approved by the US FDA.

Use of the Thermedical Ablation System for the treatment of VT is investigational and is not approved for use or sale in any market.

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