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GAITHERSBURG, Maryland - The Medical Device Dispute Resolution Panel convened in April for the second time since December - the first meeting being Acorn Cardiovascular (St. Paul, Minnesota - and this gathering was to referee a dispute between the agency and Cardima (Fremont, California) over the outcome of clinical trials for the Revelation TX microcatheter, which is designed to treat paroxysmal atrial fibrillation (PAF) in patients who have not responded to treatment with at least two drugs.

Dispute panel rebuffs Cardima's appeal for Revelation TX PMA

January 2, 2015