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

    Aid, Surgical, Viscoelastic

    PMA: P890047 · Supplement: S053 · Decision Apr 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    PROVISC Opthalmic Viscoelastic Device
    PMA Number
    P890047
    Supplement Number
    S053
    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