BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Supplement: S017 · Decision Feb 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    LAP-BAND
    PMA Number
    P000008
    Supplement Number
    S017
    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
    February 16, 2011
    Date Received
    April 27, 2010
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    12M-1013

    Advisory Committee Statement

    APPROVAL FOR LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM. THE LAP-BAND SYSTEM IS INDICATED FOR WEIGHT REDUCTION FOR PATIENTS WITH OBESITY, WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2 OR A BMI OF AT LEAST 30 KG/ M2 WITH ONE OR MORE OBESITY RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. PATIENTS WHO ELECT TO HAVE THIS SURGERY MUST MAKE THE COMMITMENT TO ACCEPT SIGNIFICANT CHANGES IN THEIR EATING HABITS FOR THE REST OF THEIR LIVES.

    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