BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S067 · Decision Dec 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MitraClip G5 System
    PMA Number
    P100009
    Supplement Number
    S067
    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
    December 31, 2024
    Date Received
    July 3, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the MitraClip G5 Delivery System and the TriClip G5 Delivery System, which include modifications to the Delivery System Handles and simplification of the IFU procedural steps to improve the ergonomics of the Clip Delivery System to enhance physician usability, as well as minor labeling, packaging, specification, and manufacturing process changes. Two of the changes, a minor specification change and an alternate Female Luer component, will also apply to the MitraClip G4 Delivery System and TriClip G4 Delivery System.

    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