BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P180024 · Decision Apr 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
    PMA Number
    P180024
    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
    April 16, 2019
    Date Received
    July 9, 2018
    Expedited Review
    N
    Docket Number
    19M-1848

    Advisory Committee Statement

    Approval for the TransPyloric Shuttle/TransPyloric Shuttle Delivery Device. The TransPyloric Shuttle/TransPyloric Shuttle Delivery Device is indicated for weight reduction in adult patients with obesity with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behavior modification program.

    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