BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Decision Jun 5, 2001
    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
    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 5, 2001
    Date Received
    February 9, 2000
    Expedited Review
    Y
    Docket Number
    02M-0250

    Advisory Committee Statement

    APPROVAL FOR THE LAP-BAND. ADJUSTABLE GASTRIC BANDING (LAGB.) SYSTEM. THE DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION FOR SEVERELY OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 OR A BMI OF AT LEAST 35 WITH ONE OR MORE SEVERE COMORBID CONDITIONS, OR THOSE WHO ARE 100 LBS. OR MORE OVER THEIR ESTIMATED IDEAL WEIGHT ACCORDING TO THE 1983 METROPOLITAN LIFE INSURANCE TABLES (USE THE MIDPOINT FOR MEDIUM FRAME). IT IS INDICATED FOR USE ONLY IN SEVERELY OBESE 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