BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070004 · Supplement: S006 · Decision Dec 18, 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
    SIENTRA SILICONE GEL BREAST IMPLANTS
    PMA Number
    P070004
    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
    Approved
    Decision Code
    APPR
    Decision Date
    December 18, 2013
    Date Received
    September 19, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL IMPLANT STYLES THAT INCORPORATE CHANGES TO THE APPROVED PMA DEVICES AND INCLUDES THE FOLLOWING STYLES: 10610-LP; 10621-MP/HP; 10712-MP; 10722-HP; 20710-LP; 10710-LP; 20721-MP/HP; 10721-MP/HP; FIVE ADDITIONAL SIZES OF THE 10512-MP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 10521-HP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 20610-LP STYLE IMPLANT; AND EIGHT ADDITIONAL SIZES OF THE 20621-MP/HP STYLE IMPLANT.

    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