BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990075 · Supplement: S003 · Decision Jun 18, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000
    PMA Number
    P990075
    Supplement Number
    S003
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 18, 2001
    Date Received
    May 14, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000.