BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Exacta External Drainage and Monitoring System (EDMS)

    Reg #: 3015531529 · FEI: 3015531529 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medtronic Neurosurgery
    Registration Number
    3015531529
    FEI Number
    3015531529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4620 North Beach Street
    City
    Fort Worth
    State
    TX
    ZIP
    76137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201118

    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
    Device, Monitoring, Intracranial Pressure GWM
    Catheter, Ventricular HCA

    Proprietary Names

    Exacta External Drainage and Monitoring System (EDMS)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility