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

    10053813001A
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129, S3UCM220, S3UCM223, S3UCM226
    LR and above aortic, THV-in-THV/SV aortic, THV-in-SV mitral
    English
    No
    N/A
    2023-05-31
    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 SystemEdwards SAPIEN 3 Transcatheter Heart ValveEdwards Commander Delivery System

    10055760001A
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, S3TF120, S3TF123, S3TF126, S3TF129, 9600CR
    Pulmonic
    English
    No
    N/A
    2023-05-31
    Request printed copy

    Fogarty Dilation Atrioseptostomy Catheter

    10045587004A_GB
    830705F
    Atrioseptostomy
    English
    No
    N/A
    2022-09-09
    Request printed copy

    Miller Balloon Atrioseptostomy Catheter

    10045588004A_GB
    830515F
    Atrioseptostomy
    English
    No
    N/A
    2022-09-09
    Request printed copy

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

    10053812001A
    9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, 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
    2023-08-09
    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 eSheath+ Introducer Set

    10057273001A_CA
    S3URCM20CA, S3URCM23CA, S3URCM26CA, S3URCM29CA, 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, French - Français
    No
    N/A
    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
Page 46 of 185

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.

If you are having difficulty obtaining your eIFU, please contact your local Edwards Representative who will be able to assist you.

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