BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P030023 · Supplement: S001 · Decision Dec 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
    PMA Number
    P030023
    Supplement Number
    S001
    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
    December 14, 2011
    Date Received
    October 19, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A TRADE NAME CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND IS INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN OR MISSING ZONULES THAT ARE SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURVILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.

    Classifications

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

    Product Code Device Name
    MRJ Ring, Endocapsular