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FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

Friday, March 26, 2021

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U.S. Food and Drug Administration

On Friday, March 26, the U.S. Food and Drug Administration approved the Harmony Transcatheter Pulmonary Valve (TPV) System to be used to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract who have severe pulmonary valve regurgitation. 

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