device pma
saveEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)
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Supplement type: Real-Time Process. Product code: NPV. Advisory committee: CV. Decision: APPR
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same company · ±60 days · 6
- device pmaEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Apr 9, 2026
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- device adverse eventEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE — Injury eventMar 31, 2026
- device adverse eventEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE — Death eventMar 31, 2026
- device adverse eventCARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS — Injury eventMar 31, 2026
- device adverse eventEDWARDS ESHEATH PLUS INTRODUCER SHEATH — Injury eventMar 31, 2026
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