BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P980044 · Supplement: S007 · Decision Jul 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    SUPARTZ
    PMA Number
    P980044
    Supplement Number
    S007
    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 7, 2009
    Date Received
    July 21, 2008
    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 FOLLOWING CHANGES TO THE MANUFACTURING PROCESS: 1) REPLACEMENT OF WFI MANUFACTURING EQUIPMENT;2) ADDITION OF A SENSOR FOR PREVENTING DOUBLE CAPPING;3) REPLACEMENT OF THE MULTIPLEXER PROCESSOR;4) ADDITION OF A SYRINGE LABEL SENSOR;5) REPLACEMENT OF THE ELECTRONIC BALANCE;6) CHANGE OF KNOCKERS USED TO PUSH RUBBER PISTONS INTO GLASS SYRINGES DURING THE FILLINGMEDIA FILL TEST (MFT);7) ADDITION OF A SECOND FILTRATION TANK IN ORDER TO FACILITATE THE MANUFACTURING OF PLASTIC ANDGLASS SYRINGE PRODUCTS ON CONSECUTIVE DAYS; AND 8) INSTALLATION OF A NEW STORAGE ROOM FOR RAW MATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUPARTZ® AND IS INDICATED FORTHE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPONDADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC 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