BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P030023 · Supplement: S004 · Decision Nov 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    CAPSULAR TENSION RING AND STABILEYES
    PMA Number
    P030023
    Supplement Number
    S004
    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
    November 13, 2015
    Date Received
    July 21, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCLUDE THE RINGJECT, A DISPOSABLE INJECTOR/DELIVERY SYSTEM DESIGNED FOR USE WITH CAPSULAR TENSION RINGS (CTRS), ADDITION OF THE INJECTOR INTO THE SAME STERILE PACKAGING PROCESS AS THE CTR AND MODIFICATION OF THE PACKAGING CONFIGURATION TO ACCOMMODATE THE COMBINED INJECTOR AND THE PRELOADED CTR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RINGJECT, MODEL 375 AND MODEL 376. CTRS ARE INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN, OR MISSING ZONULES THAT ARE SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURBILINEAR 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