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

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S006 · Decision Jul 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MITRACLIP CLIP DELIVERY SYSTEM
    PMA Number
    P100009
    Supplement Number
    S006
    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
    July 16, 2014
    Date Received
    June 16, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SECOND SUPPLIER, A CHANGE IN THE HEAT TREATMENT PROCESS AND ESTABLISHMENT OF A DEFINED RANGE OF ACCEPTABLE RAW MATERIAL HARDNESS FOR THE ACTUATOR COUPLER OF THE MITRACLIP CLIP 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