BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P140008 · Supplement: S028 · Decision Jan 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    ORBERA INTRAGASTRIC BALLOON
    PMA Number
    P140008
    Supplement Number
    S028
    Device Class
    FDA Class 3
    Product Code
    LTI
    Generic Name
    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 5, 2026
    Date Received
    November 20, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacturing site change to replace the Apollo Endosurgery Coyol, Costa Rica facility with the Boston Scientific Coyol, Costa Rica facility for the Orbera Intragastric Balloon, following acquisition of Apollo Endosurgery by Boston Scientific

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTI Implant, Intragastric For Morbid Obesity