BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990074 · Supplement: S039 · Decision Jul 5, 2017
    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
    S039
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 5, 2017
    Date Received
    June 7, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implement an Electronic Data Acquisition (EDA) System for the shell assembly vulcanization process to collect and store temperature, pressure, and time data. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.

    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