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

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P990018 · Supplement: S010 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
    PMA Number
    P990018
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 16, 2023
    Date Received
    May 23, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changing the manufacturing site for the lens blank material.

    Classifications

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

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear