BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020056 · Supplement: S026 · Decision Feb 25, 2015
    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 SILICONE-FILLED BREAST IMPLANTS
    PMA Number
    P020056
    Supplement Number
    S026
    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
    Approved
    Decision Code
    APPR
    Decision Date
    February 25, 2015
    Date Received
    August 29, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS.

    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