BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990074 · Supplement: S031 · Decision Mar 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    NATRELLE SALINE-FILLED BREAST IMPLANTS
    PMA Number
    P990074
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    FWM
    Generic Name
    Prosthesis, breast, inflatable, internal, saline
    Regulation Number
    878.3530
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 2015
    Date Received
    September 15, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256OF, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FWM Prosthesis, Breast, Inflatable, Internal, Saline