BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P820049 · Supplement: S063 · Decision Mar 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    MODELS PC-58NBM & PC-58NBZ IOLS
    PMA Number
    P820049
    Supplement Number
    S063
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 11, 1996
    Date Received
    November 13, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATION CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG)

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens