BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950008 · Supplement: S013 · Decision Jul 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    SILIKON 1000
    PMA Number
    P950008
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 18, 2016
    Date Received
    June 24, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new biological indicator to be used as an alternate process challenge device (PCD) for terminal sterilization of SILIKON 1000.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular