BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S061 · Decision Jan 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MitraClip™ G4 Clip Delivery System
    PMA Number
    P100009
    Supplement Number
    S061
    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
    January 22, 2024
    Date Received
    October 24, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    • Change in the polyester yarn supplier of the Clip Cover• Change in raw material sub-supplier and source of Polypropylene resin material for the Cover reinforcement material• Change in the incoming quality inspection tolerance for a Clip Arm dimension, and• Change in the Stomper equipment setup control range.

    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