device pma

Edwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra (PMA supplement)

March 11, 2026$EWupdated 2mo ago

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

Edwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra (PMA supplement)