Approval for the harmony™ transcatheter pulmonary valve (tpv) system. This device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i. E. , severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction >= 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
|Device||Harmony™ TPV System|
|Generic Name||Pulmonary Valve Prosthesis Percutaneously Delivered|
|Applicant Address||Medtronic, Inc. 3576 Unocal Place building A santa Rosa, CA 95403|
|Supplement Number||Date||Supplement Type|