A meeting of the Circulatory System Devices Panel was held on March 6, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application for Cryocath Technologies 7F Freezor Cardiac Cryoablation Catheter (P020045). The device is intended for cryoablation of cardiac tissue to treat patients with atrioventricular node reentrant tachycardia (AVNRT) and for mapping of the atrioventricular node. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (7-3) that the application be found ‘approvable with conditions’. The Panel’s conditions included striking mapping of the atrioventricular node from the intended use of the device, establishing a formal training program as part of the approval, postmarket evaluation to monitor for occurrence of AV block, and a minor modification to the contraindications section of the labeling to warn against the use in patients with cryoglobulinemia.
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