BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P880031 · Supplement: S014 · Decision Aug 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON D
    PMA Number
    P880031
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 2008
    Date Received
    February 15, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).

    Classifications

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

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic