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

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    PMA: P040046 · Supplement: S006 · Decision Feb 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
    Trade Name
    NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
    PMA Number
    P040046
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    FTR
    Generic Name
    Prosthesis, breast, noninflatable, internal, silicone gel-filled
    Regulation Number
    878.3540
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 14, 2014
    Date Received
    January 17, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.

    Classifications

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

    Product Code Device Name
    FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled