BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P070009 · Decision Sep 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
    PMA Number
    P070009
    Device Class
    FDA Class 3
    Product Code
    LTI
    Generic Name
    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 28, 2007
    Date Received
    April 2, 2007
    Expedited Review
    N
    Docket Number
    07M-0380

    Advisory Committee Statement

    APPROVAL FOR THE REALIZE ADJUSTABLE GASTRIC BAND. THIS DEVICE IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTS AND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OF AT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY IN MORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.

    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