Medtronic Upgrades Transcatheter Pulmonary Valve From HDE To PMA
This article was originally published in The Gray Sheet
Executive Summary
FDA approved a PMA for Medtronic’s Melody transcatheter pulmonary valve based on evidence from three clinical trials. The company says it sought the PMA to affirm the effectiveness of Melody, and not because it expects to significantly expand the volume of patients who will be treated with the device. PMA