BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P140008 · Supplement: S013 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    ORBERA Intragastric Balloon
    PMA Number
    P140008
    Supplement Number
    S013
    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
    August 17, 2018
    Date Received
    June 12, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the ORBERA Intragastric Balloon System. The device is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of >= 30 and <= 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. The maximum placement period for ORBERA is 6 months.

    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