BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950008 · Supplement: S012 · Decision Nov 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    SILICOM(TM) 1000 RETINALTAMPONADE
    PMA Number
    P950008
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 3, 2014
    Date Received
    July 7, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN FORT WORTH, TEXAS.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular