BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P160001 · Supplement: S018 · Decision Aug 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    Obalon Balloon Kit
    PMA Number
    P160001
    Supplement Number
    S018
    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 1, 2018
    Date Received
    May 16, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Obalon Balloon System. The device is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 to 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.

    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