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

    Neuromodulator For Obesity

    PMA: P130019 · Supplement: S016 · Decision Jan 22, 2018
    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
    S016
    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
    January 22, 2018
    Date Received
    December 28, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change in manufacturing site for the contract manufacturer of the Rechargeable Neuroregulator.

    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