BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P840064 · Supplement: S075 · Decision Dec 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    DISCOVISC™ Ophthalmic Viscosurgical Device
    PMA Number
    P840064
    Supplement Number
    S075
    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
    December 3, 2021
    Date Received
    April 12, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the alternate manufacturing sites located are: Lifecore Biomedical, LLC (Site 1) 3515 Lyman Boulevard Chaska, MN 55318 and Lifecore Biomedical, LLC (Site 2) 1245 Lakeview Drive Chaska, MN 55318.

    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