BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P080020 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    GEL-ONE
    PMA Number
    P080020
    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
    March 22, 2011
    Date Received
    July 31, 2008
    Expedited Review
    N
    Docket Number
    11M-0198

    Advisory Committee Statement

    APPROVAL FOR THE GEL-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO NON-PHARMACOLOGIC THERAPY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) OR 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