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

    Ring, Endocapsular

    PMA: P030023 · Supplement: S012 · Decision Oct 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    Capsular Tension Ring (275,276); RingJect (375,376)
    PMA Number
    P030023
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MRJ
    Generic Name
    Ring, endocapsular
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 6, 2025
    Date Received
    August 27, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of an alternative subcontractor for bioburden and endotoxin testing

    Classifications

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

    Product Code Device Name
    MRJ Ring, Endocapsular