BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P030023 · Decision Apr 27, 2004
    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
    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
    April 27, 2004
    Date Received
    June 17, 2003
    Expedited Review
    N
    Docket Number
    04M-0248

    Advisory Committee Statement

    APPROVAL FOR THE OCULAID CAPSULAR TENSION RING (MODEL 275 10/12 MM AND MODEL 276 11/13 MM), ALSO KNOWN AS THE STABLEYES CAPSULAR TENSION RING (MODEL 275 10/12 MM AND MODEL 276 11/13 MM), TO BE DISTRIBUTED BY ADVANCED MEDICAL OPTICS. THE DEVICE 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