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This article was originally published in The Gray Sheet
Plans to file premarket approval application for its electrophysiology catheter for radiofrequency ablation "within the next month," according to a spokesperson for the firm. Cordis joins Medtronic, with a PMA for an RF ablation catheter on file at FDA, and EP Technologies, whose RF ablation catheter won a recommendation for approval from FDA's Circulatory System Devices Panel in May ("The Gray Sheet" May 9, p. 2)
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