ATS Medical Seeks FDA Go-Ahead For Two-Arm Enable Valve Study
This article was originally published in The Gray Sheet
Executive Summary
ATS Medical will submit an investigational device exemption application to FDA by year-end for a planned two-arm U.S. pivotal study of its 3f Enable sutureless valve, CEO Mike Dale said during a March 2 panel at the RBC Capital Markets Healthcare Conference in New York City
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