BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P210005 · Supplement: S003 · Decision Dec 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    IC-8® Apthera™ Intraocular Lens (IOL)
    PMA Number
    P210005
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    POE
    Generic Name
    Extended depth of focus intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2022
    Date Received
    September 30, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the extension of the expiration dating on product labeling from 6 months to 12 months, and proposed modifications to the protocols for your respective ongoing accelerated and real-time shelf life studies.

    Classifications

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

    Product Code Device Name
    POE Extended Depth Of Focus Intraocular Lens