Cardima PMA revisited

Executive Summary

Maker of the Revelation Tx atrial fibrillation catheter plans to meet with FDA to discuss steps the company should take to earn PMA approval. On May 29, FDA's Circulatory System Devices panel voted that Cardima's study of 83 patients with drug-refractory, paroxysmal AF was inadequate to support PMA approval of the device (1"The Gray Sheet" June 2, 2003, p. 3). Cardima said it is reviewing a transcript of the meeting...