BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Neuromodulator For Obesity

    PMA: P130019 · Supplement: S008 · Decision Jun 3, 2016
    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
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    PIM
    Generic Name
    neuromodulator for obesity
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 3, 2016
    Date Received
    May 13, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to the software and hardware associated with the Rechargeable Neuroregulator (RNR) final assembly and circuit assembly test fixtures,

    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