BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990075 · Supplement: S001 · Decision Feb 27, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
    PMA Number
    P990075
    Supplement Number
    S001
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 27, 2001
    Date Received
    June 8, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MENTOR SALINE AND SPECTRUM MAMMARY PROSTHESES RETRIEVAL PROTOCOL.