BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070004 · Supplement: S045 · Decision Nov 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
    Trade Name
    Sientra Silicone Gel Breast Implants
    PMA Number
    P070004
    Supplement Number
    S045
    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 20, 2025
    Date Received
    July 23, 2024
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change to the releasing agent for Sientra Silicone Gel Breast Implants

    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