BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S003 · Decision Jul 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES
    PMA Number
    P890023
    Supplement Number
    S003
    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
    July 12, 1996
    Date Received
    September 29, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TINTING, WET PROCESSING, PACKAGING, AND STERILIZATION OF THE ABOVE-REFERENCED LENSES AT THE COMPANY'S FACILITY LOCATED AT SANTA ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757

    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