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    eIFU ELK0-012-0531 S3U KR

    10052410001B
    9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610ES14, 9600CR, S3UCM220, S3UCM223, S3UCM226
    LR and above aortic, THV-in-SV aortic, THV-in-SV mitral
    Korean – 한국어
    No
    N/A
    2023-05-12
    Request printed copy

    Edwards Transfemoral Balloon Catheter

    148110005A
    9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
    Pulmonic
    English, Swedish - Svenska, Danish - Dansk
    No
    N/A
    2021-07-19
    Request printed copy

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

    10054332001A_MDD/MDR_CA
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CA, S3URCM23CA, S3URCM26CA, S3URCM29CA, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129
    LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral, MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
    English, French - Français
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery SystemPulmonic Valve Implantation

    10051248002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, Spanish - Español, Portuguese - Português
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery SystemPulmonic Valve Implantation

    10051243002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, Swedish - Svenska, Danish - Dansk
    No
    N/A
    2023-08-29
    Request printed copy

    Système de valve cardiaque transcathéter Edwards SAPIEN 3Valve cardiaque transcathéter Edwards SAPIEN 3Système de mise en place Edwards CommanderImplantation de valve pulmonaire

    10051244002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    French - Français, Dutch - Nederlands, German - Deutsch
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transkatheter-HerzklappensystemEdwards SAPIEN 3 Transkatheter-HerzklappeEdwards Commander ApplikationssystemPulmonalklappen-Implantation

    10051245002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    German - Deutsch, French - Français, Italian - Italiano
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery SystemPulmonic Valve Implantation

    10051246002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, Czech - Česky, Hungarian - Magyar
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery SystemPulmonic Valve Implantation

    10051247002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, Polish - Polski, Slovak - Slovensky
    No
    N/A
    2023-08-29
    Request printed copy

    Edwards SAPIEN 3 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery SystemPulmonic Valve Implantation

    10051249002A - MDR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    English, Norwegian - Norsk, Finnish - Suomi
    No
    N/A
    2023-08-29
    Request printed copy
Page 22 of 116

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