BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Lens, Contact (Polymethylmethacrylate)

    PMA: P840004 · Supplement: S006 · Decision May 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Lens, Contact (Polymethylmethacrylate)
    Trade Name
    SATURN II(TM) (SYNERGICON A) CONTACT LENS
    PMA Number
    P840004
    Supplement Number
    S006
    Device Class
    FDA Unclassified
    Product Code
    HPX
    Generic Name
    Lens, contact (polymethylmethacrylate)
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 13, 1993
    Date Received
    August 24, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    HPX Lens, Contact (Polymethylmethacrylate)