BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lens, Contact (Other Material) - Daily

    PMA: P880098 · Supplement: S012 · Decision Dec 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Lens, Contact (Other Material) - Daily
    Trade Name
    MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    PMA Number
    P880098
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    HQD
    Generic Name
    Lens, contact (other material) - daily
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 2002
    Date Received
    November 19, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING.

    Classifications

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

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily