BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P080020 · Supplement: S014 · Decision Aug 3, 2015
    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
    Supplement Number
    S014
    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
    August 3, 2015
    Date Received
    May 5, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE PACKAGE INSERT AND THE PATIENT INFORMATION FOR GEL-ONE® AS FOLLOWS: 1) REVISION OF THE STATEMENT, THE SAFETY AND EFFECTIVENESS OF A REPEAT TREATMENT CYCLE OF GEL-ONE® HAVE NOT BEEN ESTABLISHED. TO THE STATEMENT, THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF GEL-ONE® HAS NOT BEEN ESTABLISHED; AND 2) CITATION OF CLINICAL STUDY DATA FOR RETREATMENT WITH GEL-ONE® IN SUPPORT OF THE REVISION OF THIS STATEMENT AS DESCRIBED ABOVE.

    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