BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060022 · Supplement: S008 · Decision Apr 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    AKREOS POSTERIOR CHAMBER INTRACULAR LENS
    PMA Number
    P060022
    Supplement Number
    S008
    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
    April 29, 2011
    Date Received
    March 18, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT THE PROPOSED CHANGE TO THE BIOBURDEN TESTING FOR THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens