BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P940015 · Supplement: S052 · Decision Jan 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    Synvisc, Synvisc-One
    PMA Number
    P940015
    Supplement Number
    S052
    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
    January 2, 2025
    Date Received
    December 3, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a precaution statement stating the device is only intended for use by healthcare professionals adequately trained to administer intra-articular injections and revisions to the Synvisc® and Synvisc-One® patient labeling to include the same advisory statement.

    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