Prospective, Non?randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve (Model 11500P) for Pulmonary Valve Replacement

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Study Title
Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve (Model 11500P) for Pulmonary Valve Replacement
Sponsor Name
Edwards Lifesciences
NCT Number
NCT02656290
IDE Number
G120108
CMS Approval Date
2016-10-13
Category
B