BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC NEUROMODULATION

    Reg #: 2182207 · FEI: 2182207 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    127
    Establishment Types
    3
    Classifications
    26

    Registration Details

    Registration Name
    MEDTRONIC NEUROMODULATION
    Registration Number
    2182207
    FEI Number
    2182207
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7000 Central Ave., N.E.
    City
    Minneapolis
    State
    MN
    ZIP
    55432
    Country
    US

    Regulatory Submissions

    510(k) Number
    K994097
    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
    Garment, Storage, Peritoneal Dialysis Catheter OAG
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Pump, Infusion, Implanted, Programmable LKK
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence QPT
    Instrument, Surgical, Non-Powered HAO
    Tape And Bandage, Adhesive KGX
    Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence NAM
    Medical Device Data System OUG
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Cover, Burr Hole GXR
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Intestinal Stimulator LNQ
    Stimulator, Brain, Implanted, For Behavior Modification MFR
    Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) OLM
    Dissector, Surgical, General & Plastic Surgery GDI
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Stimulator, Thalamic, Epilepsy, Implanted MBX
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Deep Brain Stimulation For The Treatment Of Dystonia SGS
    Implanted Subcortical Electrical Stimulator (Motor Disorders) MRU
    Brain Stimulation Programming Planning Software. QQC

    Proprietary Names

    PrimeAdvanced SureScan MRI Neurostimulator Injex Bumpy Anchor Pisces-Quad Plus Lead N'Vision Software Application Card Specify SureScan MRI Lead Pisces-Quad Compact Lead Resume II Lead RestoreUltra SureScan MRI Neurostimulator Itrel 4 Neurostimulator Resume TL Lead Titan Anchor RestoreSensor Neurostimulator Itrel 4 Neurostimulation System Stretch Coil Extension RestoreAdvanced Neurostimulator EZ Anchor Injex BiWing Anchor RestoreAdvanced SureScan MRI Neurostimulator Specify Lead Vectris SureScan Lead RestorePrime Neurostimulator Itrel EZ Programmer Synergy EZ Programmer RestoreUltra Neurostimulator RestoreSensor SureScan MRI Neurostimulator PrimeAdvanced Neurostimulator myStim Programmer N'Vision Programmer Intellis™ with AdaptiveStim™ Implantable Neurostimulator Vanta™ with AdaptiveStim™ Implantable Neurostimulator Inceptiv™ LT Implantable Neurostimulator Inceptiv™ Implantable Neurostimulator Intellis™ Pro Implantable Neurostimulator Recharger belt Screening belt Recharger Drape Lead Introducer SureTune3 MLTC Multi Lead Trialing Cable IsoMed Infusion Pump Refill Altaviva™ Patient Programmer Kit Altaviva™ Neurostimulator Patient Programmer Altaviva™ Clinician Kit Wireless Recharger Altaviva™ Clinician Programmer Kit Recharging Dock Ankle Band Pocket sizer DBS Tunneling tool Tunneling Tool Accessory Kit SenSight™ On-Point Lead Sheath Anchor Adhesive Discs Adult/Neonatal Adhesive Sensor Wrap < 3 kg > 40 kg NURO Therapy Session Kit NURO External Neurostimulator for Percutaneous Tibial Neuromodulation Paceart Optima and Mainspring Data Express Version 6 Discovery Link MDDS N'Vision Report Link Paceart System Get Connected III, Connected Systems Gateway Paceart Optima Clinic Management Component Medtronic CareLink Website DiscoveryLink MDDS Session Management MyCareLink Smart Application iOS CareLink SmartSync Host Application MyCareLink Smart Application Android CareLink Mobile Application Paceart Optima Data Transformation Engine Component CareLink SmartSync Platform iOS CareLink SmartSync Platform Android Patient Connector Patient Data Service App for Intellis Communicator SynchroMed Infusion Pump System SynchroMed II Infusion Pump System myPTM Personal Therapy Manager Ascenda Catheter Indura 1P Catheter SynchroMed® II Clinician Programmer PumpSynchroMed™ Clinician Programmer SynchroMed™ III extension passive headrest StimLoc burr hole cover StimLoc extension passer accessory kit screening cable InterStim II Neurostimulator InterStim Neurostimulator Verify Controller Verify Evaluation System InterStim Sacral Nerve Stimulation InterStim iCon Patient Programmer Verify External Neurostimulator InterStim II Sacral Nerve Stim InterStim Micro™ Implantable Neurostimulator InterStim™ SureScan™ MRI leads InterStim™ X Implantable Neurostimulator 3875 1 X 8 Subcompact Lead 1 X 8 Test Stimulation Lead Enterra Neurostimulator Activa PC Neurostimulator Access Review Therapy Controller Activa SC Neurostimulator DBS Extension Kit Access Therapy Controller Reclaim Deep Brain Stimulation Percept™ PC BrainSense™ MEROCEL SPONGE MICRO-FRANCE Medtronic Dissector Tool InterStim Therapy System InterStim iCon Programmer Model 3873 1 X 8 Lead Model 3874 1 X 8 Compact Lead Activa Tremor Control Therapy Activa RC Neurostimulator Activa Parkinsons Control Therapy Intercept™ Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology DBS Therapy for Dystonia Activa Dystonia Therapy SureTune™ 4 Software

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility