BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P950027 · Supplement: S006 · Decision Jul 19, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    HYALGAN
    PMA Number
    P950027
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    MOZ
    Generic Name
    Acid, hyaluronic, intraarticular
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 19, 2005
    Date Received
    January 7, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.

    Classifications

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

    Product Code Device Name
    MOZ Acid, Hyaluronic, Intraarticular