A meeting of the Circulatory System Devices Panel was held on May 29, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application (P020039) for the Cardima® Revelation Tx Microcatheter with NavAblator RF Ablation System.
The device is indicated for treatment of Atrial Fibrillation in patients with drug refractory paroxysmal atrial fibrillation by mapping, pacing, and ablating with a set of continuous linear lesions in the right atrium.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (7-0) that the application be found ‘not approvable’. The Panel cited concerns with primary data endpoints, inconsistent collection of data, and quantity of data obtained for the primary and key secondary endpoints.
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.