BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: N18020 · Supplement: S040 · Decision Sep 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE
    PMA Number
    N18020
    Supplement Number
    S040
    Device Class
    FDA Class 2
    Product Code
    LPN
    Generic Name
    Accessories, soft lens products
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 20, 1995
    Date Received
    May 30, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISED PACKAGE INSERT TEXT WHICH IS TO BE PRINTED ON THE 8 FL. OZ AND 15 FL. OZ. AEROSOL CANS OF THE REFERENCED DEVICE AND THE ELIMINATION OF THE PACKAGE INSERT FOR THESE SIZE CONTAINERS

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products