BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P030023 · Supplement: S002 · Decision Mar 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    OPHTEC-STABLEYES CAPSULAR TENSION RING
    PMA Number
    P030023
    Supplement Number
    S002
    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
    March 12, 2012
    Date Received
    January 5, 2012
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.

    Classifications

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

    Product Code Device Name
    MRJ Ring, Endocapsular