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Edwards SAPIEN 3 Ultra System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Commander Delivery System
10053813001A_NZ
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3UCM220, S3UCM223, S3UCM226, S3TF320, S3TF323, S3TF326, S3TF329
LR and above aortic, THV-in-THV/SV aortic, THV-in-SV mitral
English
No
N/A
2023-05-31
Edwards SAPIEN 3 System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System
10055760001A_MDD/MDR_NZ
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
Pulmonic
English
No
N/A
2023-05-31
Edwards eSheath+ Introducer Set
10056055001A_IQ
914ESP, 916ESP, S3TF320, S3TF323, S3TF326, S3TF329
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System
10051068002A_IQ
S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
2023-08-31
Edwards eSheath+ Introducer Set
10060784001A_CO
914ESP, 916ESP, S3URCM20LT, S3URCM23LT, S3URCM26LT, S3URCM29LT
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Spanish - Español
No
N/A
2024-05-30
Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System
10051068002A_LB
S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
2023-08-31
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Commander Delivery System
10056267001A_LB
S3URCM20EA, S3URCM23EA, S3URCM26EA, S3URCM29EA, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English
No
N/A
2024-03-04
Edwards eSheath+ Introducer Set
10058027001A_LB
914ESP, 916ESP, S3URCM20EA, S3URCM23EA, S3URCM26EA, S3URCM29EA, S3TF320, S3TF323, S3TF326, S3TF329
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English
No
N/A
2023-08-29
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Commander Delivery System
10060766001A_CO
S3URCM20LT, S3URCM23LT, S3URCM26LT, S3URCM29LT, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Spanish - Español
No
N/A
2024-05-30
10007176001
10007176001
HEM1
Danish - Dansk
No
1.0.0.25
2016-09-30
IFUs and Operator Manuals are subject to change; the most current version is available on this site. If you do not find the document you need, or have difficulty accessing the document please contact Edwards Support at 1-888-570-4016 or at tech_support@edwards.com. To order a printed copy (free of charge) search for the desired IFU or Manual and use the shopping cart functionality.
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