BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P840064 · Supplement: S025 · Decision Mar 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    DUOVISC VISCOELASTIC SYSTEM
    PMA Number
    P840064
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 2004
    Date Received
    February 17, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic