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

    Heart-Valve, Non-Allograft Tissue

    PMA: P130011 · Supplement: S001 · Decision Jul 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    SOLO SMART STENTLESS HEART VALVE
    PMA Number
    P130011
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 22, 2015
    Date Received
    June 22, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue