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    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

    10037619001A_SI - MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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
    2023-11-03
    Request printed copy

    Transkateetriga südameklapisüsteemid Edwards SAPIEN 3, SAPIEN 3 Ultra jaSAPIEN 3 Ultra RESILIATranskateetriga südameklapid Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra jaEdwards SAPIEN 3 Ultra RESILIAPaigaldussüsteem Edwards Commander

    10037630002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    Estonian - Eesti, Latvian - Latviešu, Lithuanian - Lietuvių
    No
    N/A
    2025-08-26
    Request printed copy

    Σύστημα διακαθετηριακής καρδιακής βαλβίδας Edwards SAPIEN 3, SAPIEN 3Ultra και SAPIEN 3 Ultra RESILIAΔιακαθετηριακές καρδιακές βαλβίδες Edwards SAPIEN 3, Edwards SAPIEN 3 Ultraκαι Edwards SAPIEN 3 Ultra RESILIAΣύστημα τοποθέτησης Edwards Commander

    10037628002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    Greek - ελληνικά, Bulgarian - Български, Romanian - Română
    No
    N/A
    2025-08-26
    Request printed copy

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

    10037627002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    English, Norwegian - Norsk, Finnish - Suomi
    No
    N/A
    2025-08-26
    Request printed copy

    Système de valve cardiaque transcathéter Edwards SAPIEN 3, SAPIEN 3 Ultra etSAPIEN 3 Ultra RESILIASystème de valve cardiaque transcathéter Edwards SAPIEN 3,Edwards SAPIEN 3 Ultra et Edwards SAPIEN 3 Ultra RESILIASystème de mise en place Edwards Commander

    10037621002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    French - Français, Dutch - Nederlands, German - Deutsch
    No
    N/A
    2025-08-26
    Request printed copy

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

    10037625002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    English, Polish - Polski, Slovak - Slovensky
    No
    N/A
    2025-08-26
    Request printed copy

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

    10037626002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    English, Spanish - Español, Portuguese - Português
    No
    N/A
    2025-08-26
    Request printed copy

    Edwards SAPIEN 3, SAPIEN 3 Ultra und SAPIEN 3 Ultra RESILIA TranskatheterHerzklappensystemeEdwards SAPIEN 3, Edwards SAPIEN 3 Ultra und Edwards SAPIEN 3 Ultra RESILIATranskatheter-HerzklappenEdwards Commander Applikationssystem

    10037623002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    German - Deutsch, French - Français, Italian - Italiano
    No
    N/A
    2025-08-26
    Request printed copy

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

    10037619002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    English, Swedish - Svenska, Danish - Dansk
    No
    N/A
    2025-08-26
    Request printed copy

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

    10037624002A-MDR
    S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 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, Asymptomatic
    English, Czech - Česky, Hungarian - Magyar
    No
    N/A
    2025-08-26
    Request printed copy
Page 86 of 188

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