device pma

Edwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve (PMA supplement)

March 11, 2026$EWupdated 2mo ago

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Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Edwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve (PMA supplement)