BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950008 · Supplement: S006 · Decision Dec 22, 2003
    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
    S006
    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
    December 22, 2003
    Date Received
    December 15, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR THE FINISHED PRODUCT VISCOSITY RANGE, I.E., FROM THE RANGE OF 900 TO 1200 CS TO THE RANG OF 900 TO 1250 CS.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular