BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P030023 · Supplement: S009 · Decision Aug 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    Capsular Tension Ring (CTR) and RingJect
    PMA Number
    P030023
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MRJ
    Generic Name
    Ring, endocapsular
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 1, 2024
    Date Received
    March 30, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Capsular Tension Ring (CTS) and RingJect.

    Classifications

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

    Product Code Device Name
    MRJ Ring, Endocapsular