BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990075 · Supplement: S004 · Decision Sep 5, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
    PMA Number
    P990075
    Supplement Number
    S004
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2001
    Date Received
    July 10, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) AN INCREASE IN THE THICKNESS OF THE SHELL RADIUS/BASE FOR STYLE 5000PT AND 2) A DECREASE IN THICKNESS OF THE TEXTURED LAYER FROM 0.02" TO 0.01" FOR STYLES 5000, 5000PT, 6000 AND 6000PT. THE SECOND CHANGE EFFECTIVELY WITHDRAWS THE APPROVED CHANGE IN SUPPLEMENT 2.