BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Corneal, Refractive

    PMA: P150034 · Supplement: S008 · Decision Oct 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    Raindrop Near Vision Inlay
    PMA Number
    P150034
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LQE
    Generic Name
    Implant, corneal, refractive
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 9, 2019
    Date Received
    August 19, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval to temporarily suspend the New Enrollment PAS due to not distributing or marketing of the device.

    Classifications

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

    Product Code Device Name
    LQE Implant, Corneal, Refractive