This article was originally published in The Gray Sheet
Executive SummaryAwaiting final FDA decision on a premarket approval application for its radiofrequency cardiac ablation system following its response to an approvable letter, the company says in an Aug. 2 press release. The approvable letter, "received a few days ago, contained several items that required a response to the FDA." EP technologies says. "The company had been working with the agency on an ongoing basis and, therefore, was able to address the agency's items in an expeditious manner." EP Technologies' RF ablation system was granted expedited review status by FDA in January and gained a unanimous recommendation for approval from the agency's Circulatory System Devices Panel in May ("The Gray Sheet" May 9, p. 2)
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