BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P940015 · Supplement: S010 · Decision Sep 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    SYNVISC HYLAN G-F 20
    PMA Number
    P940015
    Supplement Number
    S010
    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
    September 12, 2003
    Date Received
    August 15, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PATIENT PACKAGE INSERT FOR SYNVISC THAT ARE INTENDED TO STRENGTHEN THE INFORMATION FOR PATIENTS BY INCREASING THE TYPE SIZE, DECREASING THE READING LEVEL, MORE FULLY DESCRIBING THE U.S. CLINICAL TRIAL, DESCRIBING THE SIGNS OF AN ALLERGIC REACTION, AND BY MAKING OTHER REVISIONS TO THE INSERT.

    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