Cardima
This article was originally published in The Gray Sheet
Executive Summary
CDRH officials tell Cardima at a June 18 meeting that a new randomized clinical trial of the Revelation Tx ablation catheter will be necessary to earn approval for an atrial fibrillation indication. The meeting was prompted by a May 28 non-approvable letter rejecting the firm's initial application for the second time (1"The Gray Sheet" June 7, 2003, p. 10)...
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