BEUDAMED
    FDA Registration Active 🇺🇸 United States

    N'Vision Software Application Card

    Reg #: 3003120897 · FEI: 3003120897 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Registration Number
    3003120897
    FEI Number
    3003120897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Road
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    PMA Number
    P840001

    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
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB

    Proprietary Names

    N'Vision Software Application Card EZ Anchor Synergy EZ Programmer Injex Bumpy Anchor Resume TL Lead RestoreAdvanced SureScan MRI Neurostimulator RestoreSensor SureScan MRI Neurostimulator PrimeAdvanced Neurostimulator RestoreSensor Neurostimulator Vectris SureScan Lead Titan Anchor myStim Programmer Itrel 4 Neurostimulator RestoreUltra SureScan MRI Neurostimulator Itrel EZ Programmer RestorePrime Neurostimulator Injex BiWing Anchor PrimeAdvanced SureScan MRI Neurostimulator Specify Lead Stretch Coil Extension Pisces-Quad Compact Lead Resume II Lead Itrel 4 Neurostimulation System Pisces-Quad Plus Lead Specify SureScan MRI Lead N'Vision Programmer RestoreAdvanced Neurostimulator RestoreUltra Neurostimulator Intellis™ with AdaptiveStim™ Implantable Neurostimulator Vanta™ with AdaptiveStim™ Implantable Neurostimulator Inceptiv™ Implantable Neurostimulator Intellis™ Pro Implantable Neurostimulator Inceptiv™ LT Implantable Neurostimulator

    Establishment Types

    Manufacture Medical Device