BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990075 · Supplement: S006 · Decision Aug 9, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MENTOR SALINE-FILLED BREAST IMPLANTS
    PMA Number
    P990075
    Supplement Number
    S006
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 9, 2001
    Date Received
    July 26, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.