BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Supplement: S048 · Decision Dec 12, 2023
    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
    S048
    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
    December 12, 2023
    Date Received
    May 25, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    a product line extension, referred to as ReShape Lap-Band® 2.0 FLEX System, which contains the FLEX Tubing. The FLEX Tubing acts as a reservoir within the ReShape Lap-Band® 2.0 FLEX System and can expand to hold extra saline out of the band cuff, allowing the band stoma to temporarily dilate and facilitate the passage of a food bolus through the band

    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