BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040046 · Decision Feb 20, 2013
    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
    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 20, 2013
    Date Received
    December 6, 2004
    Expedited Review
    N
    Docket Number
    13M-0255

    Advisory Committee Statement

    APPROVAL FOR THE NATRELLE® 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR WOMEN FOR THE FOLLOWING USES (PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY; AND 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.

    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