BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S078 · Decision Aug 20, 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 G5 Delivery System
    PMA Number
    P100009
    Supplement Number
    S078
    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
    August 20, 2025
    Date Received
    July 21, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the Instructions for Use (IFU) to clarify information on several preparation steps for the MitraClip G5 and TriClip G5 Delivery Systems devices due to the design differences with the MitraClip G4 and TriClip G4 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