BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ligaments And Tendons, Synthetic

    PMA: P850069 · Supplement: S006 · Decision Dec 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Ligaments And Tendons, Synthetic
    Trade Name
    KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
    PMA Number
    P850069
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LML
    Generic Name
    LIGAMENTS AND TENDONS, SYNTHETIC
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 31, 1992
    Date Received
    December 26, 1989
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    93M-0018

    Classifications

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

    Product Code Device Name
    LML Ligaments And Tendons, Synthetic