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

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S046 · Decision Aug 16, 2022
    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
    S046
    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
    August 16, 2022
    Date Received
    July 22, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implement a revised sampling plan for torque strength testing of the Press-Fit Assembly of the MitraClip G4 Clip Delivery System 01410.

    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