BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040046 · Supplement: S008 · Decision Nov 7, 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 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
    PMA Number
    P040046
    Supplement Number
    S008
    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
    November 7, 2014
    Date Received
    August 11, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL NATRELLE 410 DEVICE STYLES AND SIZES INCLUDING: ONE (1) SIZE OF STYLE FL 410; ONE (1) SIZE OF STYLE ML 410; TWO (2) SIZES OF STYLE LL 410; FOUR (4) SIZES OF STYLE LM 410; TEN (10) SIZES OF STYLE LF 410; NINE (9) SIZES OF STYLE FX 410; NINE (9) SIZES OF STYLE MX 410; AND SEVEN (7) SIZES OF STYLE LX 410.

    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