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    Edwards Transfemoral Balloon Catheter

    10055129001A-MDD
    9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
    Pulmonic
    English, French - Français
    No
    N/A
    2023-03-02
    Request printed copy

    Cathéter à ballonnet transfémoral Edwards

    148111005A_TN
    9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
    Pulmonic
    French - Français, Dutch - Nederlands, German - Deutsch
    No
    N/A
    2021-06-25
    Request printed copy

    Edwards SAPIEN 3 Ultra SystemEdwards SAPIEN 3 Ultra Transcatheter Heart ValveEdwards Commander Delivery System

    148439004B
    9610TF20, 9610TF23, 9610TF26, 9750TFX20, 9750TFX23, 9750TFX26, 9600CR, S3UCM220, S3UCM223, S3UCM226
    LR and above aortic
    English, Spanish - Español, Portuguese - Português
    No
    N/A
    2022-08-08
    Request printed copy

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

    10051068001A - MDR_IR
    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
    N/A
    2022-09-19
    Request printed copy

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

    10051252001A - MDR_TR
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
    MDR Pulmonic
    Russian - Русский, Turkish - Türkçe, Croatian - Hrvatski
    No
    N/A
    2022-09-12
    Request printed copy

    eIFU ELK0-012-0531 KR

    10053022001A
    S3TF120, 9600TFX20, 9610ES14, 9350BC16, 9610TF20, 9600CR, S3TF123, 9600TFX23, 9350BC20, 9610TF23, S3TF126, 9600TFX26, 9350BC23, 9610TF26, S3TF129, 9600TFX29, 9610ES16, 9350BC25, 9610TF29
    LR and above aortic, THV-in-SV aortic, THV-in-SV mitral
    Korean – 한국어
    No
    N/A
    2023-05-12
    Request printed copy

    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

    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
Page 21 of 129

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