BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040046 · Supplement: S013 · Decision Aug 5, 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 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS
    PMA Number
    P040046
    Supplement Number
    S013
    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
    August 5, 2015
    Date Received
    December 30, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES THAT INCLUDE: FOUR (4) SIZES OF STYLE FL 410; FOUR (4) SIZES OF STYLE ML 410; ONE (1) SIZE OF STYLE LM 410; THREE (3) SIZES OF STYLE LL 410; TWO (2) SIZES OF STYLE LF 410; FOUR (4) SIZES OF STYLE FX 410; FOUR (4) SIZES OF STYLE MX 410; AND SIX (6) SIZES OF STYLE LX 410. THESE TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES ENCOMPASS A RANGE OF: VOLUME = 140-775 CC; WIDTH = 9.5-15.5 CM; HEIGHT = 7.6-16.0 CM; AND PROJECTION = 2.9-7.1 CM.

    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