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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Neuromodulator For Obesity

    PMA: P130019 · Decision Jan 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Neuromodulator For Obesity
    Trade Name
    MAESTRO RECHARGEABLE SYSTEM
    PMA Number
    P130019
    Device Class
    FDA Class 3
    Product Code
    PIM
    Generic Name
    neuromodulator for obesity
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    January 14, 2015
    Date Received
    June 21, 2013
    Expedited Review
    N
    Docket Number
    15M-0201

    Advisory Committee Statement

    APPROVAL FOR THE MAESTRO® RECHARGEABLE SYSTEM. THIS DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION IN PATIENTS AGED 18 YEARS THROUGH ADULTHOOD WHO HAVE A BODY MASS INDEX (BMI) OF 40 TO 45 KG/M2, OR A BMI OF 35 TO 39.9 KG/M2 WITH ONE OR MORE OBESITY RELATED CO-MORBID CONDITIONS, AND HAVE FAILED AT LEAST ONE SUPERVISED WEIGHT MANAGEMENT PROGRAM WITHIN THE PAST FIVE YEARS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIM Neuromodulator For Obesity