BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S076 · Decision Aug 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Automated Insulin Dosing Device System, Single Hormonal Control
    Trade Name
    MiniMed 770G System
    PMA Number
    P160017
    Supplement Number
    S076
    Device Class
    FDA Class 3
    Product Code
    OZP
    Generic Name
    Automated insulin dosing device system, single hormonal control
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 31, 2020
    Date Received
    November 1, 2019
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    20M-1838

    Advisory Committee Statement

    Approval of the MiniMed 770G System to expand the indications for use to use users down to 2 years old and to update the pump communication protocol to Bluetooth Low Energy (BLE).

    Classifications

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

    Product Code Device Name
    OZP Automated Insulin Dosing Device System, Single Hormonal Control