BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P840064 · Supplement: S068 · Decision Apr 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System
    PMA Number
    P840064
    Supplement Number
    S068
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 24, 2018
    Date Received
    March 27, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Use of a compounding isolator for sterile incorporation of Sodium Hyaluronate during production of PROVISC and PROVISC as part of DUOVISC, and for additional formulation rooms 4 and 5 for manufacture of PROVISC, PROVISC as part of DUOVISC, VISCOAT, and VISCOAT as part of DUOVISC.

    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