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The U.S. Food and Drug Administration (FDA) has not approved the CardioFocus Endoscopic Ablation System for general use.

The Endoscopic Ablation System is an investigational device in the United States , and is under IDE status (Investigational Device Exemption). In the United States , this investigational product can only be used in pre-marketing clinical trials approved by the FDA. For further information, please contact CardioFocus, Inc.

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