BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950008 · Supplement: S007 · Decision Oct 30, 2009
    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
    S007
    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
    October 30, 2009
    Date Received
    May 4, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS OF SPECIFICATION RANGES FOR VISCOSITY AND MOLECULAR WEIGHT. THE CURRENT SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 900 ¿ 1,250 CS AND 32,850 ¿ 47,000 DALTONS, RESPECTIVELY. THE PROPOSED REGULATORY ACCEPTANCE SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 980 ¿ 1,350 CS AND 31,000 ¿ 44,500 DALTONS, RESPECTIVELY.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular