BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P980044 · Supplement: S009 · Decision Jul 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    SUPARTZ JOINT FLUID THERAPY
    PMA Number
    P980044
    Supplement Number
    S009
    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 8, 2009
    Date Received
    February 26, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DISTRIBUTION SITE CHANGE FROM ONE ADDRESS IN MEMPHIS, TENNESSEE TO ANOTHER ADDRESS IN MEMPHIS, TENNESSEE.

    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