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

    Intraocular Lens

    PMA: P080004 · Supplement: S024 · Decision Aug 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    iSert Intraocular Lenses (IOLs)
    PMA Number
    P080004
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 21, 2019
    Date Received
    July 23, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modifications to the 1-piece IOL haptic inspection method and acceptance criteria.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens