BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030053 · Supplement: S013 · Decision Feb 24, 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
    MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
    PMA Number
    P030053
    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
    February 24, 2014
    Date Received
    January 25, 2013
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF SEVEN STYLES INCLUDING FOUR SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5650BC, 350-57000BC, 350-5750BC, AND 350-5800BC; AND THREE SILTEX ROUND ULTRA HIGH PROFILE DEVICES: 354-5590, 354-5650, AND 354-5700.

    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