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Medtronic Upgrades Transcatheter Pulmonary Valve From HDE To PMA

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

FDA approved a PMA for Medtronic PLC’s Melody transcatheter pulmonary valve, which has been available in the U.S. since 2010 under a humanitarian device exemption, based on the results of three clinical trials, the company announced Feb. 3.

Under the HDE, Melody was approved based on a lower effectiveness threshold compared to a PMA, and was restricted to use in an annual population of no larger than 4,000...

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