BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S028 · Decision Dec 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    ocufilcon D Sift (Hydrophilie) Contact Lenses
    PMA Number
    P890023
    Supplement Number
    S028
    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
    December 19, 2017
    Date Received
    August 4, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the test specifications of the saline solutions that are manufactured at the CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico and used in the packaging of ocufilcon D Soft (Hydrophilic) Contact Lenses in blister containers.

    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