BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P010029 · Supplement: S001 · Decision Feb 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    NUXFLEXXA (SODIUM HYALURONATE)
    PMA Number
    P010029
    Supplement Number
    S001
    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
    February 27, 2006
    Date Received
    January 13, 2005
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) CHANGING THE STORAGE CONDITIONS SPECIFIED IN THE PRODUCT LABELING FROM, ?STORE IN A COLD DARK PLACE [2 ? 8 DEGREES C (36-46 DEGREES F)]. PROTECT FROM LIGHT. DO NOT FREEZE?. 2) CHANGE THE SPECIFIED SHELF LIFE TIME IN THE LABELING FORM 3 YEARS (AT REFRIGERATED TEMPERATURES) TO 12 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO 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