BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Supplement: S039 · Decision Oct 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    Lap-Band Adjustable Gastric Banding System
    PMA Number
    P000008
    Supplement Number
    S039
    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
    October 2, 2017
    Date Received
    July 5, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the long-term data from the HERO-002 post-approval study, the addition of the MR Conditional labeling claim, and the addition of warnings for adverse events associated with device erosion and device migration/twisting/slipping.

    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