Cardima Revelation Tx re-submission
This article was originally published in The Gray Sheet
Executive Summary
Amended PMA for paroxysmal atrial fibrillation treatment with linear ablation catheter is submitted to FDA Jan. 20, roughly seven months after the agency denied market go-ahead. "Additional data and analysis" included in the re-submission respond to efficacy concerns raised during a May Circulatory System Devices Panel meeting that resulted in a unanimous vote against approval. The amendment follows a Jan. 9 FDA guidance for catheter ablation systems treating AF, recommending 12-month follow-up (1"The Gray Sheet" Jan. 19, 2004, p. 7)...
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