BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P090022 · Supplement: S005 · Decision Sep 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P090022
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 22, 2011
    Date Received
    July 26, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO AMEND THE APPROVED LABELING TO ALLOW FOR THE USE OF THE ASICO SOFTIP INJECTION SYSTEM, MODEL NUMBER AS-9300 WITH THE SOFTEC HD, SOFTEC I AND SOFTEC HD PS INTRAOCULAR LENSES (IOLS).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens