BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MMT-5120 Simplera Sync sensor

    Reg #: 3004209178 · FEI: 3004369318 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Registration Number
    3004209178
    FEI Number
    3004369318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK
    City
    Juncos
    State
    PR
    ZIP
    00777
    Country
    US

    Regulatory Submissions

    PMA Number
    P160017

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

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

    Proprietary Names

    MMT-5120 Simplera Sync sensor MMT-7512 One-press Serter MMT-7715 Charger, Replacement (Grey) MMT-1760 MiniMed 670G Insulin Pump Kit MMT-7810 Guardian Link 3 Transmitter Kit (GST3C) MMT-7811 Guardian Link 3 Transmitter (GST3C) MMT-7020 Enlite 3 Sensor 5pk MMT-7736 Tester 2pk MMT-1780 MiniMed 670G Insulin Pump MMT-7910NA Guardian Link (3) Transmitter Kit (GST5C) MMT-7911NA Guardian Link (3) Transmitter (GST5C) MMT-1880 MiniMed 770G Insulin Pump MMT-1890 MiniMed 770G Insulin Pump Kit MG/DL MMT-1884 MiniMed 780G Insulin Pump MMT-1884L MiniMed 780G Insulin Pump MMT-7040 Guardian Sensor 4 MMT-7841 Guardian 4 Transmitter MMT-1894 MiniMed 780G Insulin Pump Kit

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device