Medtronic Transcatheter Pulmonary Valve Study Begins Under Draft FDA Feasibility Study Guidance
This article was originally published in The Gray Sheet
In granting IDE approval for a feasibility study of Medtronic’s Native Outflow Tract Transcatheter Pulmonary Valve, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies.
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