BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P090031 · Supplement: S003 · Decision Feb 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    MONOVISC
    PMA Number
    P090031
    Supplement Number
    S003
    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
    February 4, 2015
    Date Received
    November 7, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM <= 0.05% TO <= 0.03% W/W TO BE IN ACCORDANCE WITH RESIDUAL SOLVENT TESTING LIMITS UNDER USP GENERAL CHAPTER <467>, TO REVISE THE STABILITY TESTING PROTOCOL FOR MONOVISC, AND TO EXTEND THE SHELF LIFE OF MONOVISC FROM 2 YEARS TO 3 YEARS UTILIZING THIS REVISED STABILITY TESTINGPROTOCOL.

    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