Stimulator, Spinal-Cord, Implanted (Pain Relief)
FDA product code GZB · Class II (moderate risk) · 21 CFR 882.5880 · Neurology
139510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Medtronic Vascular 56
- Advanced Neuromodulation Systems 24
- Neuromed, Inc. 15
- Stimwave Technologies Incorporated 9
- Boston Scientific Neuromodulation Corporation 7
- Anulex Technologies, Inc. 4
- Cordis Corp. 3
- St Jude Medical 3
- Medamicus, Inc. 2
- Medtronic Neurological 2
- Medtronic, Inc. 2
- St. Jude Medical Neuromodulation 2
- Regulatory & Marketing Services, Inc. 1
- Micronet Medical, Inc. 1
- Advanced Neuromodulation System,Inc 1
- Medtronic Inc.,Neurological Division. 1
- Advanced Neuromodulation Systems, Inc. (Ans Inc.) 1
- Biomedical Life Systems, Inc. 1
- Northumbria Biologicals , Ltd. 1
- Instromedix, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | Boston Scientific Neuromodulation | 08/23/2024SE |
| K221376 | Nalu Neurostimulation SystemGZB · Special | Boston Scientific Neuromodulation | 06/10/2022SE |
| K203547 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/25/2021SE |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional | Boston Scientific Neuromodulation | 11/09/2020SE |
| K201618 | Nalu Neurostimulation SCS systemGZB · Special | Boston Scientific Neuromodulation | 07/15/2020SE |
| K191466 | SandShark Injectable Anchor (SIA) SystemGZB · Traditional | Stimwave Technologies, Inc. | 11/07/2019SE |
| K190960 | Nalu Lead Blank (50cm)GZB · Traditional | Boston Scientific Neuromodulation | 07/11/2019SE |
| K182720 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | Stimwave Technologies Incorporated | 03/29/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/22/2019SE |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional | Stimwave Technologies Incorporated | 09/19/2018SE |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…GZB · Traditional | Stimwave Technologies Incorporated | 11/03/2017SE |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…GZB · Traditional | Stimwave Technologies Incorporated | 05/02/2017SE |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…GZB · Traditional | Stimwave Technologies Incorporated | 12/16/2016SE |
| K160600 | Freedom Spinal Cord Stimulator SystemGZB · Traditional | Stimwave Technologies Incorporated | 08/26/2016SE |
| K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…GZB · Traditional | Anchor Innovation Medical (A.I.M.) | 07/27/2015SE |
| K150517 | Freedom Spinal Cord Stimulator SystemGZB · Traditional | Stimwave Technologies Incorporated | 06/05/2015SE |
| K141399 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | Stimwave Technologies Incorporated | 10/10/2014SE |
| K140272 | Swift-Lock AnchorGZB · Traditional | St Jude Medical | 05/02/2014SE |
| K130545 | Multi Lead Trial CableGZB · Traditional | St Jude Medical | 06/18/2013SE |
| K123299 | MTS System, Wide-Space Quattrode Percutaneous LeadsGZB · Traditional | St. Jude Medical Neuromodulation | 01/18/2013SE |
| K113611 | Rapid ProgrammerGZB · Traditional | St Jude Medical | 04/20/2012SE |
| K113805 | Fixate Tissue BandGZB · Traditional | Anulex Technologies, Inc. | 02/23/2012SE |
| K113400 | Fixate Tissue BandGZB · Special | Anulex Technologies, Inc. | 12/16/2011SE |
| K112214 | Octrodex(Tm), Quattrodex(Tm), Introdex(Tm), Epidural Needle, StyletsGZB · Traditional | St. Jude Medical Neuromodulation | 11/17/2011SE |
| K112849 | Fixate Tissue BandGZB · Special | Anulex Technologies, Inc. | 10/27/2011SE |
| K111462 | Fixate Tissue BandGZB · Traditional | Anulex Technologies, Inc. | 09/08/2011SE |
| K102523 | Multi-Lead Trialing Cable Model 355531GZB · Special | Medtronic, Inc. | 10/26/2010SE |
| K092371 | Swift-Lock Anchor, Model 1192GZB · Traditional | Advanced Neuromodulation Systems | 12/23/2009SE |
| K091993 | Rapid Programmer, Version 3.3.0GZB · Special | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | 07/31/2009SE |
| K090907 | Penta Lead Kits, Models: 3227-3234GZB · Traditional | Advanced Neuromodulation Systems | 06/02/2009SE |
| K081208 | Cinch Anchor, Model 1194GZB · Traditional | Advanced Neuromodulation Systems | 07/18/2008SE |
| K072462 | Wide Spaced Quattrode LeadsGZB · Special | Advanced Neuromodulation Systems | 10/11/2007SE |
| K070847 | Trial Cable, 3009GZB · Special | Advanced Neuromodulation Systems | 04/11/2007SE |
| K063080 | Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsGZB · Special | Advanced Neuromodulation Systems | 12/12/2006SE |
| K062041 | Model 3875 1 X 8 SC Test Stimulation LeadGZB · Special | Medtronic, Inc. | 08/16/2006SE |
| K053250 | Ans 90 CM and 110 CM (3100 and 3200 Series) Lead KitGZB · Special | Advanced Neuromodulation Systems | 12/15/2005SE |
| K052374 | Rapid Progeammer 3.0GZB · Traditional | Advanced Neuromodulation Systems | 11/22/2005SE |
| K052418 | Axxess Butterfly AnchorGZB · Special | Advanced Neuromodulation Systems | 09/26/2005SE |
| K051773 | Model 3873 1* 8 and Model 3874 1* 8 Compact Test Stimulation LeadsGZB · Special | Medtronic Inc.,Neurological Division. | 07/28/2005SE |
| K050922 | Ans SCS Accessory KitGZB · Special | Advanced Neuromodulation Systems | 05/18/2005SE |
| K050633 | Trial Cable Retention ClipGZB · Special | Advanced Neuromodulation Systems | 04/21/2005SE |
| K040609 | Rapid ProgrammerGZB · Special | Advanced Neuromodulation Systems | 03/25/2004SE |
| K040568 | Polyether Urethane Material Change in Neurostimulation LeadsGZB · Special | Medtronic Vascular | 03/25/2004SE |
| K033757 | MTS Multiprogram Trial Stimulator SystemGZB · Traditional | Advanced Neuromodulation Systems | 01/30/2004SE |
| K033429 | Lamitrode Spinal Cord Stimulation LeadsGZB · Special | Advanced Neuromodulation Systems | 12/04/2003SE |
| K033016 | Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad…GZB · Traditional | Medtronic Neurological | 10/30/2003SE |
| K032751 | Modification to Renew Lead ExtensionGZB · Special | Advanced Neuromodulation Systems | 10/06/2003SE |
| K032349 | PlacerGZB · Traditional | Advanced Neuromodulation Systems | 10/03/2003SE |
| K032034 | Ans Axxess Percutaneous LeadGZB · Traditional | Advanced Neuromodulation Systems | 10/03/2003SE |
| K032561 | Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation…GZB · Special | Medtronic Vascular | 09/11/2003SE |
| K030461 | A127 Lead ExtensionGZB · Traditional | Advanced Neuromodulation Systems | 04/24/2003SE |
| K030674 | Modification to Axxess Spinal Cord Stimulation LeadGZB · Special | Advanced Neuromodulation Systems | 03/28/2003SE |
| K030118 | Rapid ProgrammarGZB · Traditional | Advanced Neuromodulation Systems | 03/11/2003SE |
| K022222 | Lamitrode S-Series (S4 and S8) LeadsGZB · Special | Advanced Neuromodulation System,Inc | 08/08/2002SE |
| K021518 | PaindocGZB · Special | Advanced Neuromodulation Systems | 06/06/2002SE |
| K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18GZB · Traditional | Medamicus, Inc. | 01/24/2002SE |
| K013063 | Grip Lock Anchor, Model 411374GZB · Traditional | Medtronic Neurological | 12/11/2001SE |
| K010300 | Medtronic Model 7495LZ Low Impedance ExtensionGZB · Traditional | Medtronic Vascular | 08/01/2001SE |
| K010008 | Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80XX, 81XX, and 82XXGZB · Traditional | Micronet Medical, Inc. | 07/16/2001SE |
| K011584 | Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain ReliefGZB · Traditional | Medtronic Vascular | 06/22/2001SE |
| K000445 | Medtronic Model 7499 ExtensionGZB · Traditional | Medtronic Vascular | 04/28/2000SE |
| K994097 | Medamicus Epidural IntroducerGZB · Traditional | Medamicus, Inc. | 03/01/2000SE |
| K992946 | Renew ReceiverGZB · Special | Advanced Neuromodulation Systems | 09/24/1999SE |
| K991784 | Renew Lead ExtensionGZB · Special | Advanced Neuromodulation Systems | 06/24/1999SE |
| K990469 | Lamitrode LeadsGZB · Traditional | Advanced Neuromodulation Systems | 06/03/1999SE |
| K990104 | Medtronic Model 7495 Extension KitGZB · Special | Medtronic Vascular | 02/09/1999SE |
| K972906 | Medtronic Twist Lock Anchor (Partnumber 103953/3550TLA)GZB · Traditional | Medtronic Vascular | 02/06/1998SE |
| K971756 | Medtronic Model 3998 LeadGZB · Traditional | Medtronic Vascular | 02/03/1998SE |
| K972043 | Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 ScreenerGZB · Traditional | Medtronic Vascular | 08/22/1997SE |
| K964172 | Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads or TTLGZB · Traditional | Medtronic Vascular | 07/03/1997SE |
| K953742 | Bifurcated Y-ExtensionGZB · Traditional | Medtronic Vascular | 11/19/1996SE |
| K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode)GZB · Traditional | Neuromed, Inc. | 05/22/1996SE |
| K955291 | DualscreenGZB · Traditional | Medtronic Vascular | 05/17/1996SE |
| K954886 | Model Nos. 7495 and 501826 ExtensionsGZB · Traditional | Medtronic Vascular | 11/27/1995SE |
| K941342 | Pain DocGZB · Traditional | Regulatory & Marketing Services, Inc. | 10/13/1995SE |
| K952459 | Medtronic Model 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C Leads or, Transverse…GZB · Traditional | Medtronic Vascular | 08/30/1995SE |
| K943537 | Model 3470 X-Trel RF ReceiverGZB · Traditional | Medtronic Vascular | 04/12/1995SE |
| K934065 | Medtronic Mattrix 3271/3272 Neurostimulation SystemGZB · Traditional | Medtronic Vascular | 02/14/1995SE |
| K950127 | Alternate 100% Eto Sterilization Process and Alternate Sterilization FaccilityGZB · Traditional | Medtronic Vascular | 01/30/1995SE |
| K945103 | Temp and Permanent Neuro Leads (Various Models)GZB · Traditional | Medtronic Vascular | 01/11/1995SE |
| K930536 | Neuromed Octrode Model MNR-88A-B-C Neurostim RecGZB · Traditional | Neuromed, Inc. | 12/15/1994SE |
| K930498 | Neuromed Octrode Model MNT-98 Neurostimulator TranGZB · Traditional | Neuromed, Inc. | 12/12/1994SE |
| K940416 | Neurological Leads (Packaging Modification)GZB · Traditional | Medtronic Vascular | 07/18/1994SE |
| K936099 | Neurological Lead AccessoriesGZB · Traditional | Medtronic Vascular | 07/11/1994SE |
| K934938 | Temporary Screening Lead/Catheter KitGZB · Traditional | Medtronic Vascular | 06/14/1994SE |
| K932202 | Model 3862A & B 3863A & B Temp. Lead Screening KitGZB · Traditional | Medtronic Vascular | 05/04/1994SE |
| K932948 | Medtronic Model 3625 Screener SystemGZB · Traditional | Medtronic Vascular | 02/03/1994SE |
| K930242 | Introde INT-8GZB · Traditional | Neuromed, Inc. | 02/02/1994SE |
| K921319 | Neuromed Model OCA-30 Octode and Model SCA-30GZB · Traditional | Neuromed, Inc. | 05/05/1993SE |
| K924522 | Medtronic Model 3080 Pisces-Quad LeadGZB · Traditional | Medtronic Vascular | 03/18/1993SE |
| K923931 | Medtronic Model 3487A Pisces-Quad LeadGZB · Traditional | Medtronic Vascular | 03/18/1993SE |
| K923567 | Medtronic Model 3888 Pisces-Quad Plus LeadGZB · Traditional | Medtronic Vascular | 11/05/1992SE |
| K921558 | Medtronic Models 3983A and 3983B Resume LeadsGZB · Traditional | Medtronic Vascular | 07/07/1992SE |
| K913993 | Medtronic Models 3982 A,B,C&D Stag Array Res LeadsGZB · Traditional | Medtronic Vascular | 02/07/1992SE |
| K913934 | Medtronic Model 3586 Resume LeadGZB · Traditional | Medtronic Vascular | 01/22/1992SE |
| K914433 | Medtronic MDLS 3487/3487A/3587/3587A SCS LeadsGZB · Traditional | Medtronic Vascular | 12/23/1991SE |
| K913442 | Medtronic 3625 Screener SystemGZB · Traditional | Medtronic Vascular | 11/22/1991SE |
| K912764 | Medtronic Model 3861 Temporary Screening Lead KitGZB · Traditional | Medtronic Vascular | 11/22/1991SE |
| K905569 | Electro-Nerve Stimulator Tens,Model Systems Plus/AGZB · Traditional | Biomedical Life Systems, Inc. | 06/27/1991SE |
| K905596 | Neuromed Octrode Model MNR-88B/88C Neurostim SystGZB · Traditional | Neuromed, Inc. | 03/11/1991SE |
| K905402 | Antigenz ChlamydiaGZB · Traditional | Northumbria Biologicals , Ltd. | 03/11/1991SE |
| K903690 | Medtronic (R) Model 3625 ScreenerGZB · Traditional | Medtronic Vascular | 02/14/1991SE |
| K910199 | Medtronic Model 3487A Pisces-Quad LeadGZB · Traditional | Medtronic Vascular | 02/11/1991SE |
| K905407 | Model 3487A PISCES-QUAD,3587A RESUME,3586 ResumeGZB · Traditional | Medtronic Vascular | 02/01/1991SE |
| K905255 | Neuromed Model 1992 LS Lamitrode LeadGZB · Traditional | Neuromed, Inc. | 01/25/1991SE |
| K903814 | Neuromed TS8 Test StimulatorGZB · Traditional | Neuromed, Inc. | 01/16/1991SE |
| K901499 | Neuromed Octrode Model MNR-88 W/98 Adapter Neuro.GZB · Traditional | Neuromed, Inc. | 06/29/1990SE |
| K890061 | Model 3586 Resume LeadGZB · Traditional | Medtronic Vascular | 04/30/1990SE |
| K892884 | Medtronic Model 3530 Percutaneous ExtensionGZB · Traditional | Medtronic Vascular | 08/07/1989SE |
| K885033 | Model 3487A Pisces Epidural LeadGZB · Traditional | Medtronic Vascular | 01/17/1989SE |
| K884948 | Model 3587A Resume Epidural LeadGZB · Traditional | Medtronic Vascular | 01/17/1989SE |
| K883780 | Xtrel, Model Number 3425GZB · Traditional | Medtronic Vascular | 11/30/1988SE |
| K881491 | Model 3487A Pisces Epidural LeadGZB · Traditional | Medtronic Vascular | 05/25/1988SE |
| K873675 | Modified #3587 Resume SE-4/#3487 Pisces-QuadGZB · Traditional | Medtronic Vascular | 10/06/1987SE |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel)GZB · Traditional | Neuromed, Inc. | 10/06/1986SE |
| K855107 | Medtronic Model 3422A Transmitter Antenna KitGZB · Traditional | Medtronic Vascular | 05/09/1986SE |
| K860185 | Unistim UNT-1M Neurostimulator TransmitterGZB · Traditional | Neuromed, Inc. | 04/04/1986SE |
| K860158 | 8-CHANNEL Multiprog Implant Spinal Cord StimulatorGZB · Traditional | Neuromed, Inc. | 03/07/1986SE |
| K853643 | Multistim Laminectomy ElectrodeGZB · Traditional | Neuromed, Inc. | 11/14/1985SE |
| K852326 | Unistim UNT-1GZB · Traditional | Neuromed, Inc. | 11/14/1985SE |
| K852920 | Quadra Cath ELECT(3MM Sizes) 1990J, JF, JP + JPFGZB · Traditional | Neuromed, Inc. | 10/10/1985SE |
| K852827 | Cordis External Neural Stimulator Model 911AGZB · Traditional | Cordis Corp. | 08/14/1985SE |
| K844115 | Medtronic 3465 SE-4F Receiver/Extension for SpinalGZB · Traditional | Medtronic Vascular | 02/06/1985SE |
| K841584 | Medtronic Resume SE-4 3587-LEAD-SPINALGZB · Traditional | Medtronic Vascular | 05/14/1984SE |
| K833990 | Spinal Cord Stimulation Sys SE-4GZB · Traditional | Medtronic Vascular | 03/19/1984SE |
| K833809 | Neural Stimulator MonitorGZB · Traditional | Instromedix, Inc. | 12/01/1983SE |
| K831746 | Pisces #3487 Epidural Lead for SpinalGZB · Traditional | Medtronic Vascular | 08/11/1983SE |
| K823530 | Stimucord External Neural Stim. 911AGZB · Traditional | Cordis Corp. | 12/15/1982SE |
| K820988 | Medtronic #1992-2 Dual Rate TransmitterGZB · Traditional | Medtronic Vascular | 06/23/1982SE |
| K812155 | Medtronic Dual Channel Spinal Cord StimGZB · Traditional | Medtronic Vascular | 10/08/1981SE |
| K812154 | Medtronic #3484 Pisces Epidural LeadGZB · Traditional | Medtronic Vascular | 08/20/1981SE |
| K811655 | Myelostat Dorsal Cord StimulatorGZB · Traditional | Medtronic Vascular | 07/01/1981SE |
| K810182 | Programmable Spinal Coral Stim. SystemGZB · Traditional | Electronic Diagnostics, Inc. | 04/03/1981SE |
| K810319 | Cordis Stimucord External Neutral StimGZB · Traditional | Cordis Corp. | 02/19/1981SE |
| K801384 | Myelostat Dorsal Cord Stimulator, Etc.GZB · Traditional | Medtronic Vascular | 07/08/1980SE |
| K800193 | Medtronic Pisces Generation II Lead KitGZB · Traditional | Medtronic Vascular | 02/05/1980SE |
| K790790 | Pisces-Selector XGZB · Traditional | Medtronic Vascular | 05/25/1979SE |
| K780758 | Neurological Screening Stimulator M 3623GZB · Traditional | Medtronic Vascular | 05/19/1978SE |
| K780001 | Epidural Lead - Model 3481GZB · Traditional | Medtronic Vascular | 01/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2719-2014 Class II | Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St.…The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The… | St. Jude Medical, Inc. | 07/29/2014Terminated |
| Z-2718-2014 Class II | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St.…The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The… | St. Jude Medical, Inc. | 07/29/2014Terminated |
| Z-1425-2010 | Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude…Directions For Use of product incorrectly stated lead compatibility information. | Advanced Neuromodulation Systems, Inc | 02/22/2010Terminated |
| Z-2241-2008 | Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at…Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling… | Medtronic Neuromodulation | 05/21/2008Terminated |