BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reherniation Reduction Device

    PMA: P160050 · Supplement: S002 · Decision May 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Reherniation Reduction Device
    Trade Name
    Barricaid Anular Closure Device
    PMA Number
    P160050
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    QES
    Generic Name
    Reherniation reduction device
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2019
    Date Received
    March 11, 2019
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step.

    Classifications

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

    Product Code Device Name
    QES Reherniation Reduction Device