BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S081 · Decision Oct 17, 2025
    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 DELIVERY SYSTEM
    PMA Number
    P100009
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 17, 2025
    Date Received
    September 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the substitution of commercially available DC shaft components used for process monitoring with vendor inspected DC shaft components with specific reject reasons that do not impact bond integrity, and a change in the incoming sampling plan of 8 components from 100% inspection to RQL

    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