Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Tendyne Transcatheter Mitral Valve System

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems

EDWARDS CERTITUDE DELIVERY SYSTEM

FDA UDI

Edwards Lifesciences LLC·00690103194142·EDWARDS CERTITUDE DELIVERY SYSTEM

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

FDA UDI

Edwards Lifesciences LLC·00690103201321·Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

SAPIEN 3 Ultra Delivery System

FDA UDI

Edwards Lifesciences LLC·00690103201246·U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm)

Edwards Certitude Delivery System

FDA UDI

Edwards Lifesciences LLC·00690103201444·Edwards Certitude Delivery System

SAPIEN 3 Ultra System

FDA UDI

Edwards Lifesciences LLC·00690103207828·SAPIEN 3 Ultra valve with Commander delivery Sy...

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

FDA UDI

Edwards Lifesciences LLC·00690103201338·Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

SAPIEN 3 Ultra delivery system

FDA UDI

Edwards Lifesciences LLC·00690103201260·U.S. Edwards SAPIEN 3 Ultra Delivery System (29mm)

COMMANDER

FDA UDI

Edwards Lifesciences LLC·00690103217001·Commander DS with SAPIEN 3 Ultra Loader

SAPIEN 3 Ultra RESILIA

FDA UDI

Edwards Lifesciences LLC·00690103215793·SAPIEN 3 Ultra RESILIA Transcatheter Heart Valv...

SAPIEN 3 Ultra delivery system

FDA UDI

Edwards Lifesciences LLC·00690103201239·Edwards SAPIEN 3 Ultra Delivery System (20mm) US

SAPIEN 3 Ultra RESILIA

FDA UDI

Edwards Lifesciences LLC·00690103215809·SAPIEN 3 Ultra RESILIA Transcatheter Heart Valv...

EDWARDS CERTITUDE DELIVERY SYSTEM

FDA UDI

Edwards Lifesciences LLC·00690103194166·EDWARDS CERTITUDE DELIVERY SYSTEM

EDWARDS CRIMPER

FDA UDI

Edwards Lifesciences LLC·00690103193978·

SAPIEN 3 Ultra System

FDA UDI

Edwards Lifesciences LLC·00690103207811·SAPIEN 3 Ultra valve with Commander Delivery Sy...

Edwards Certitude Delivery System

FDA UDI

Edwards Lifesciences LLC·00690103201451·Edwards Certitude Delivery System

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

FDA UDI

Edwards Lifesciences LLC·00690103201314·Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

EDWARDS CRIMPER

FDA UDI

Edwards Lifesciences LLC·00690103198331·

EDWARDS CERTITUDE DELIVERY SYSTEM

FDA UDI

Edwards Lifesciences LLC·00690103194135·EDWARDS CERTITUDE DELIVERY SYSTEM