ClearanceBrief
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

CodeDeviceRecords
LKKPump, Infusion, Implanted, Programmable96
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief36
MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor30
EZWStimulator, Electrical, Implantable, For Incontinence10
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)2
BTAPump, Portable, Aspiration (Manual Or Powered)1
FFTElectrode, Ph, Stomach1
GEIElectrosurgical, Cutting & Coagulation & Accessories1
GXRCover, Burr Hole1
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)1
HAWNeurological Stereotaxic Instrument1
JCCPh Buffer1
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)1
LNQIntestinal Stimulator1
QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence1
QQCBrain Stimulation Programming Planning Software.1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 23, 2021DEN210003SureTune4 Software
Medtronic Neuromodulation
QQC

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 22, 2026Medtronic Neuromodulation
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Open, Classified
EZWNone listed
Oct 22, 2026Medtronic 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
QONNone listed
May 28, 2026Medtronic Neuromodulation
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
May 28, 2026Medtronic Neuromodulation
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
May 14, 2026Medtronic 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
LKKNone listed
Jan 9, 2026Medtronic 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
LGWNone listed
Dec 23, 2025Medtronic 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
LGWNone listed
Apr 30, 2025Medtronic Neuromodulation
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Open, Classified
EZWNone listed
Apr 8, 2025Medtronic Neuromodulation
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Open, Classified
LGWNone listed
Apr 1, 2025Medtronic Neuromodulation
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Open, Classified
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Nov 13, 2024Medtronic 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
LGWNone listed
Oct 23, 2024Medtronic Neuromodulation
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Open, Classified
MHYNone listed
Oct 21, 2024Medtronic Neuromodulation
SynchroMed II Infusion Pump. Product Number: 8637-20
Open, Classified
LKKNone listed
Oct 17, 2024Medtronic Neuromodulation
Vanta Implantable Neurostimulator (INS), Model 977006
Open, Classified
LGWNone listed
Sep 6, 2024Medtronic Neuromodulation
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Open, Classified
EZWNone listed
Jul 24, 2024Medtronic 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
MHYNone listed
Jul 12, 2024Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Open, Classified
LKKNone listed
Apr 26, 2024Medtronic Neuromodulation
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Open, Classified
LGWNone listed
Jan 22, 2024Medtronic Neuromodulation
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Open, Classified
LGWNone listed
Dec 22, 2023Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Open, Classified
LKKNone listed
Dec 22, 2023Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Open, Classified
LKKNone listed
Nov 20, 2023Medtronic Neuromodulation
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Open, Classified
LGWNone listed
Nov 3, 2023Medtronic Neuromodulation
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Completed
MHYNone listed
Oct 18, 2023Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
Open, Classified
MHYNone listed
Sep 29, 2023Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Terminated
LGWNone listed
Aug 10, 2023Medtronic Neuromodulation
Medtronic InterStim Ground Pad REF 041826
Open, Classified
EZWNone listed
Jul 21, 2023Medtronic Neuromodulation
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Open, Classified
LGWNone listed
Jun 29, 2023Medtronic Neuromodulation
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Open, Classified
LGWNone listed
Apr 19, 2023Medtronic 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
MHYNone listed
Jan 6, 2023Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Open, Classified
LGWNone listed
Jan 6, 2023Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Open, Classified
LGWNone listed
Jan 6, 2023Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Open, Classified
LGWNone listed
Jan 6, 2023Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Open, Classified
LGWNone listed
Jan 6, 2023Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Open, Classified
LGWNone listed
Aug 25, 2022Medtronic Neuromodulation
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Open, Classified
LGWNone listed
Jul 26, 2022Medtronic Neuromodulation
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Open, Classified
LGWNone listed
May 23, 2022Medtronic 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
LGWNone listed
Apr 22, 2022Medtronic 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
EZWNone listed
Mar 30, 2022Medtronic Neuromodulation
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Open, Classified
MRUNone listed
Mar 30, 2022Medtronic Neuromodulation
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Open, Classified
MHYNone listed
Nov 4, 2021Medtronic 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
LGWNone listed
Nov 4, 2021Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Open, Classified
MHYNone listed
Nov 4, 2021Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Open, Classified
EZWNone listed
Oct 19, 2021Medtronic Neuromodulation
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Open, Classified
MHYNone listed
Sep 23, 2021Medtronic Neuromodulation
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Open, Classified
MHYNone listed
Jul 9, 2021Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Open, Classified
LGWNone listed

Newest 50 of 184.

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