Company ยท US
Medtronic Neuromodulation
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2021. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
184recalls (7 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | 96 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 36 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | 30 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 10 |
| MRU | Implanted Subcortical Electrical Stimulator (Motor Disorders) | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| FFT | Electrode, Ph, Stomach | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GXR | Cover, Burr Hole | 1 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| JCC | Ph Buffer | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| LNQ | Intestinal Stimulator | 1 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | 1 |
| QQC | Brain Stimulation Programming Planning Software. | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medtronic Neuromodulation InterStim Percutaneous Extensions
EXT 3560022 ISTM II PERC
3560022
EXT 3560030 ISTM MICRO PERC
3560030 Open, Classified |
EZW | None listed |
| Oct 22, 2026 | Medtronic Neuromodulation InterStim SureScan MRI Leads 978A1 & 978B1:
LEAD 978A128 ISTM MICRO 28CM SSMRI TINED
978A128
LEAD 978A133 ISTM MICRO 33CM SSMRI TINED
978A133
LEAD 978A141 ISTM MICRO 41CM SSMRI TINED
978A141
L Open, Classified |
QON | None listed |
| May 28, 2026 | Medtronic Neuromodulation Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor Open, Classified |
MHY | None listed |
| May 28, 2026 | Medtronic Neuromodulation Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor Open, Classified |
MHY | None listed |
| May 14, 2026 | Medtronic Neuromodulation Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices:
1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A;
2. PROG CT900B C Open, Classified |
LKK | None listed |
| Jan 9, 2026 | Medtronic Neuromodulation A71200 Vanta" Clinician Programmer Application (CP App) version
2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900). Open, Classified |
LGW | None listed |
| Dec 23, 2025 | Medtronic Neuromodulation Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:
CT900A PROG CT900A CLINICIAN TABLET US
CT900B PROG CT900B CLINICIAN TABLET EU -UK
CT900C PROG CT90 Open, Classified |
LGW | None listed |
| Apr 30, 2025 | Medtronic Neuromodulation Enhanced Verify Evaluation Handset (CFN HH90130FA) Open, Classified |
EZW | None listed |
| Apr 8, 2025 | Medtronic Neuromodulation Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators Open, Classified |
LGW | None listed |
| Apr 1, 2025 | Medtronic Neuromodulation A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, C Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B Open, Classified |
LKK | None listed |
| Nov 13, 2024 | Medtronic Neuromodulation Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator I Open, Classified |
LGW | None listed |
| Oct 23, 2024 | Medtronic Neuromodulation Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. Open, Classified |
MHY | None listed |
| Oct 21, 2024 | Medtronic Neuromodulation SynchroMed II Infusion Pump. Product Number: 8637-20 Open, Classified |
LKK | None listed |
| Oct 17, 2024 | Medtronic Neuromodulation Vanta Implantable Neurostimulator (INS), Model 977006 Open, Classified |
LGW | None listed |
| Sep 6, 2024 | Medtronic Neuromodulation Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator. Open, Classified |
EZW | None listed |
| Jul 24, 2024 | Medtronic Neuromodulation A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081 Open, Classified |
MHY | None listed |
| Jul 12, 2024 | Medtronic Neuromodulation Medtronic Ascenda Intrathecal Catheter, Models:
a) 8780 (114 cm);
b) 8781 (140 cm);
c) 8784 (catheter pump revision kit) Open, Classified |
LKK | None listed |
| Apr 26, 2024 | Medtronic Neuromodulation Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator Open, Classified |
LGW | None listed |
| Jan 22, 2024 | Medtronic Neuromodulation Model A710 Intellis Clinician Programmer Application, version 2.0.97 Open, Classified |
LGW | None listed |
| Dec 22, 2023 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637-40, Programmable pump Open, Classified |
LKK | None listed |
| Dec 22, 2023 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637-20, Programmable pump Open, Classified |
LKK | None listed |
| Nov 20, 2023 | Medtronic Neuromodulation Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Open, Classified |
LGW | None listed |
| Nov 3, 2023 | Medtronic Neuromodulation LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. Completed |
MHY | None listed |
| Oct 18, 2023 | Medtronic Neuromodulation SenSight Connector Plug, Model Number B31061. Open, Classified |
MHY | None listed |
| Sep 29, 2023 | Medtronic Neuromodulation Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Terminated |
LGW | None listed |
| Aug 10, 2023 | Medtronic Neuromodulation Medtronic InterStim Ground Pad REF 041826 Open, Classified |
EZW | None listed |
| Jul 21, 2023 | Medtronic Neuromodulation A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Open, Classified |
LGW | None listed |
| Jun 29, 2023 | Medtronic Neuromodulation Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation Open, Classified |
LGW | None listed |
| Apr 19, 2023 | Medtronic Neuromodulation Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation Open, Classified |
MHY | None listed |
| Jan 6, 2023 | Medtronic Neuromodulation Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E Open, Classified |
LGW | None listed |
| Jan 6, 2023 | Medtronic Neuromodulation Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D Open, Classified |
LGW | None listed |
| Jan 6, 2023 | Medtronic Neuromodulation Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C Open, Classified |
LGW | None listed |
| Jan 6, 2023 | Medtronic Neuromodulation Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B Open, Classified |
LGW | None listed |
| Jan 6, 2023 | Medtronic Neuromodulation Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A Open, Classified |
LGW | None listed |
| Aug 25, 2022 | Medtronic Neuromodulation Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy. Open, Classified |
LGW | None listed |
| Jul 26, 2022 | Medtronic Neuromodulation Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy. Open, Classified |
LGW | None listed |
| May 23, 2022 | Medtronic Neuromodulation Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy. Open, Classified |
LGW | None listed |
| Apr 22, 2022 | Medtronic Neuromodulation MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) Inte Terminated |
EZW | None listed |
| Mar 30, 2022 | Medtronic Neuromodulation Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 Open, Classified |
MRU | None listed |
| Mar 30, 2022 | Medtronic Neuromodulation Percept BrainSense Implantable Neurostimulator (INS), Model B35200 Open, Classified |
MHY | None listed |
| Nov 4, 2021 | Medtronic Neuromodulation Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and Restor Open, Classified |
LGW | None listed |
| Nov 4, 2021 | Medtronic Neuromodulation Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator. Open, Classified |
MHY | None listed |
| Nov 4, 2021 | Medtronic Neuromodulation Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator. Open, Classified |
EZW | None listed |
| Oct 19, 2021 | Medtronic Neuromodulation Model B35200 - Percept PC BrainSense Implantable Neurostimulator Open, Classified |
MHY | None listed |
| Sep 23, 2021 | Medtronic Neuromodulation Clinician Programmer Application (CPA) model A610 Clinician Software Application Open, Classified |
MHY | None listed |
| Jul 9, 2021 | Medtronic Neuromodulation Medtronic Vectris SureScan MRI, Catalog Numbers:
a) 977A260
b) 977A275
c) 977A290 Open, Classified |
LGW | None listed |
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