BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P140012 · Supplement: S006 · Decision Jan 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    RESHAPE INTEGRATED DUAL BALLOON SYSTEM
    PMA Number
    P140012
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LTI
    Generic Name
    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 6, 2017
    Date Received
    December 7, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change Receipt inspection of packaging materials, reseal Valve Sealant packaging after inspection, and increase HEPA filtration and particulate alert and action levels.

    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