First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation
XTalks
APRIL 6, 2021
It was approved under the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA. The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.
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