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    Edwards eSheath+ Introducer Set

    10061821001A_TN
    S3URCM20EA, S3URCM23EA, S3URCM26EA, S3URCM29EA, 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, French - Français, Russian - Русский
    No
    N/A
    2024-11-21
    Request printed copy

    Система сердечного клапана для чрескатетерного введения Edwards SAPIEN 3Сердечный клапан для чрескатетерного введения Edwards SAPIEN 3Система доставки Edwards Commander

    10051086002A_BY
    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
    Russian - Русский, Turkish - Türkçe, Croatian - Hrvatski
    No
    N/A
    2023-08-31
    Request printed copy

    Система сердечного клапана для чрескатетерного введения Edwards SAPIEN 3 Сердечный клапан для чрескатетерного введения Edwards SAPIEN 3 Система доставки Edwards Commander Имплантация легочного клапана

    10051252002A_BY
    S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
    MDR Pulmonic
    Russian - Русский, Turkish - Türkçe, Croatian - Hrvatski
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Commander Delivery System

    60058152001A_SA
    9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 9600CR, S3URCM20EA, S3URCM23EA, S3URCM26EA, S3URCM29EA, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, S3TF320, S3TF323, S3TF326, S3TF329, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20U, 9610TF23U, 9610TF26U, S3UCM220, S3UCM223, S3UCM226
    MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral, Asymptomatic
    English
    No
    N/A
    Request printed copy

    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 - MDR_FR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320P, S3TF323P, S3TF326P, S3TF329P
    MDR Pulmonic
    French - Français, Dutch - Nederlands, German - Deutsch
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards eSheath+ Introducer Set

    10061821001A_TN_PUL
    914ESP, 916ESP, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, French - Français, Russian - Русский
    No
    N/A
    2024-11-21
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System

    10038503002A
    9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29
    Pulmonic
    English
    No
    Request printed copy

    Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System

    10033860009A
    9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9600IS18, 9600IS21, 9630TA20, 9630TA23, 9630TA26, 9630TA29, 9750TFX20, 9750TFX23, 9750TFX26
    LR and above symptomatic aortic, HR and above aortic ViV, THV-in-THV/SV HR aortic, THV-in-SV HR and above mitral
    English
    No
    Request printed copy

    Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Commander Delivery System

    10033859015A
    9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9750CM20, 9750CM23, 9750CM26, 9750CM29
    LR and above symptomatic/ asymptomatic severe aortic stenosis, HR and above aortic ViV, THV-in-THV/SV HR aortic, HV-in-SV MR and above mitral
    English
    No
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System

    60058958001A_AR
    S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
    Asymptomatic, 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
    2026-03-17
    Request printed copy
Page 59 of 149

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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