MEDTRONIC NEUROMODULATION

FDA Device Registration & Listing · Minneapolis, MN, US · Registration 2182207

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2182207
FEI Number
2182207
Entity Name
MEDTRONIC NEUROMODULATION
City/State/Country
Minneapolis, MN, US
Establishment Address
7000 Central Ave., N.E., Minneapolis, MN 55432, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062041
PMA Number
N/A

All Registered 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 Lead Introducer 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 N'Vision Software Application Card SynchroMed Infusion Pump System SynchroMed II Infusion Pump System myPTM Personal Therapy Manager Ascenda Catheter Indura 1P Catheter N'Vision Programmer 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 N'Vision Software Application Card N'Vision Programmer InterStim Micro™ Implantable Neurostimulator InterStim™ SureScan™ MRI leads InterStim™ X Implantable Neurostimulator 3875 1 X 8 Subcompact Lead 1 X 8 Test Stimulation Lead

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2007-12-06
QRB Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy Unknown Class 3 N/A 2007-12-06
OAG Garment, Storage, Peritoneal Dialysis Catheter Physical Medicine Class 1 890.5050 2015-11-05
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-26
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2017-11-03
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2010-11-29
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2010-11-29
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2007-12-26
QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown Class 3 N/A 2025-09-19
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2012-02-28
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 1992-12-02
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 1992-12-02
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-26
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2006-08-07
NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence Gastroenterology, Urology Class 2 876.5310 2015-10-23
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-05-03
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2006-04-21
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-26
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2008-06-09
GXR Cover, Burr Hole Neurology Class 2 882.5250 2008-06-09
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2007-12-12
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-12
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-26
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2007-12-26
EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology Class 3 876.5270 2007-12-26
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2007-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K190960 Boston Scientific Neuromodulation Nalu Lead Blank (50cm) 2019-07-11
K150517 Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator System 2015-06-05
K945103 Medtronic Vascular TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) 1995-01-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2007 Medtronic Neuromodulation 3
Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
Z-0037-2008 Medtronic Neuromodulation 3
Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.
Z-0040-2008 Medtronic Neuromodulation 3
Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.
Z-0022-2018 St. Jude Medical, Inc. 3
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018 St. Jude Medical, Inc. 3
Proclaim DRG Implantable Pulse Generator Model 3664

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182207. Last updated year: 2026. Please use registration number 2182207 when referencing this establishment in official correspondence.
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