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Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
10059844002A_AU
S3PAS4045AP, 29AP4045
Pulmonic
English
No
N/A
2025-04-29
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent SAPIEN 3 THV with SAPIEN 3 Pulmonic Delivery System
10059845002A_AU
S3PAS4045AP, 9600TFX29, 9630PL29, 9600CR
Pulmonic
English
No
N/A
2025-04-29
Edwards eSheath+ Introducer Set
10063017001A_NZ
914ESP, 916ESP, S3PAS4045AP, S3URCM20AP, S3URCM23AP, S3URCM26AP, S3URCM29AP, S3UCM220, S3UCM223, S3UCM226, S3TF320, S3TF323, S3TF326, S3TF329
Pulmonic, 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
2025-02-11
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
10059844002A_NZ
S3PAS4045AP, 29AP4045
Pulmonic
English
No
N/A
2025-04-29
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent SAPIEN 3 THV with SAPIEN 3 Pulmonic Delivery System
10059845002A_NZ
S3PAS4045AP, 9600TFX29, 9630PL29, 9600CR
Pulmonic
English
No
N/A
2025-04-29
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Commander Delivery System
10051087002A - MDR_AL
S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29
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 eSheath+ Introducer Set
10056055001A - MDR_AL
914ESP, 916ESP, S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226
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
Système de valve cardiaque transcathéter Edwards SAPIEN 3 Valve cardiaque transcathéter Edwards SAPIEN 3 Système de mise en place Edwards Commander
10051073002A_TN
S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2023-08-31
Système de valve cardiaque transcathéter Edwards SAPIEN 3 Valve cardiaque transcathéter Edwards SAPIEN 3 Système de mise en place Edwards Commander Implantation de valve pulmonaire
10051244002A_TN
S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR Pulmonic
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2023-08-29
Edwards SAPIEN 3 Transcatheter Heart Valve – Edwards COMMANDER Kit
60052811001A
S3TF120, S3TF123, S3TF126, S3TF129, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9610ES14, 9610ES16, 9350BC16, 9350BC20, 9350BC23, 9350BC25, 9600CR, 96402, 96406
LR and above (no ViV) aortic, THV-in-THV/SV aortic, THV-in-SV mitral
Chinese (Traditional) - 繁體中文,
English
No
2025-08-10
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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