BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P070004 · Supplement: S033 · Decision Oct 27, 2021
    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 OPUS Silicone Gel Breast Implants
    PMA Number
    P070004
    Supplement Number
    S033
    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
    October 27, 2021
    Date Received
    August 6, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.

    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