BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990075 · Supplement: S002 · Decision Dec 22, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MENTOR SALINE-FILLED MAMMARY PROSTHESES
    PMA Number
    P990075
    Supplement Number
    S002
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 2000
    Date Received
    October 23, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT.