BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S065 · Decision Jun 20, 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
    S065
    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
    June 20, 2024
    Date Received
    April 22, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    alternate model numbers under the existing trade name for the MitraClip G4 System, and alternate trade name and model numbers for the TriClip G4 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