BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850079 · Supplement: S063 · Decision Feb 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
    PMA Number
    P850079
    Supplement Number
    S063
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2014
    Date Received
    December 10, 2012
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURE OF THE DEVICE ON ANOTHER MANUFACTURING LINE AND FURTHER THAT ORDERS WITH LOW VOLUME REQUIREMENTS WILL BE LATHED ON THE FRONT SURFACE, RATHER THAN FULLY MOLDED AS LARGE VOLUME ORDERS ARE.

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear