BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P110005 · Supplement: S004 · Decision Jul 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    GELSYN-3
    PMA Number
    P110005
    Supplement Number
    S004
    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 10, 2020
    Date Received
    June 29, 2020
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for inclusion of the routine use of bioindicators to monitor efficacy of the sterilization cycle for every batch of GELSYN-3.

    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