BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Supplement: S018 · Decision Jun 18, 2010
    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
    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
    June 18, 2010
    Date Received
    May 21, 2010
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE INSTRUCTIONS FOR USE TO ADD ¿DATA FROM A POST-APPROVAL STUDY SHOWED AN ESTIMATED EXPLANT RATE OF 6.5% PER YEAR OVER THE FIRST FIVE YEARS FOLLOWING IMPLANTATION¿ TO THE ADVERSE EVENTS SECTION.

    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