BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P980044 · Supplement: S027 · Decision Dec 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    VISCO-3
    PMA Number
    P980044
    Supplement Number
    S027
    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
    December 21, 2015
    Date Received
    July 8, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VISCO-3. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.

    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