BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S082 · Decision Feb 25, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MitraClip™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW)
    PMA Number
    P100009
    Supplement Number
    S082
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 25, 2026
    Date Received
    November 26, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor design changes to the clip locking mechanism in the implant and to the delivery system handle of the MitraClip G5 and TriClip G5 Delivery Systems.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NKM Mitral Valve Repair Devices