BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S040 · Decision Jan 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL)
    PMA Number
    P030002
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    NAA
    Generic Name
    Lens, intraocular, accommodative
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 19, 2022
    Date Received
    December 22, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.

    Classifications

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

    Product Code Device Name
    NAA Lens, Intraocular, Accommodative