BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N18033 · Supplement: S030 · Decision May 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
    PMA Number
    N18033
    Supplement Number
    S030
    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
    May 14, 1997
    Date Received
    May 2, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MAKE A MINOR CHANGE IN THE INITIATOR RATIO (INCREASED AMOUNT) FOR THE ACUVUE(R) (ETAFILCON A) CONTACT LENS, WHICH WAS APPROVED AS N18-033/S29 ON OCTOBER 7, 1996. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE CURRENT TRADE NAME WITH NO CHANGE TO THE INDICATIONS FOR USE OR THE ESTABLISHED SHELF-LIFE.

    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