Product code LGW ยท Class 3
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
0510(k)s in 12 months (0 all time)
5recalls in 12 months (96 all time)
0recalls that name a 510(k)
Top companies in LGW
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 36 |
| Abbott Medical | 0 | 19 |
| Boston Scientific Neuromodulation Corporation | 0 | 10 |
| Advanced Bionics Corp | 0 | 8 |
| Advanced Neuromodulation Systems | 0 | 8 |
| St. Jude Medical | 0 | 8 |
| QiG Group LLC | 0 | 3 |
| Medtronic Neurological | 0 | 2 |
| Nuvectra | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Boston Scientific Neuromodulation Corporation INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;
INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator ( Open, Classified |
LGW | None listed |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific Model SC-4318, Clik X Anchor
REF: M365SC43180 Open, Classified |
LGW | 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 |
| Nov 7, 2025 | Abbott Medical Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 Open, Classified |
LGW | 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 |
| 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 17, 2024 | Medtronic Neuromodulation Vanta Implantable Neurostimulator (INS), Model 977006 Open, Classified |
LGW | None listed |
| Aug 14, 2024 | Boston Scientific Neuromodulation Corporation WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Open, Classified |
LGW | 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 |
| Nov 20, 2023 | Medtronic Neuromodulation Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Open, Classified |
LGW | None listed |
| Sep 29, 2023 | Medtronic Neuromodulation Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Terminated |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Infinity 7 Implantable Pulse Generator REF 6662
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Infinity 5 Implantable Pulse Generator REF 6660
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim DRG Implantable Pulse Generator REF 3664
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with u Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim Plus 7 Implantable Pulse Generator REF 3672
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads wit Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim Plus 5 Implantable Pulse Generator REF 3670
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads wit Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim" XR 7 Implantable Pulse Generator REF 3662
(previously known as Proclaim" 7 Elite IPG)
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be conne Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim XR 5 Implantable Pulse Genterator REF 3660
(previously known as Proclaim" 5 Elite IPG) Model 3660
Product Description:
The implantable pulse generator (IPG) is an electronic device designed Open, Classified |
LGW | 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 |
| 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 |
| 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 |
| Jul 9, 2021 | Medtronic Neuromodulation Medtronic Vectris SureScan MRI, Catalog Numbers:
a) 977A260
b) 977A275
c) 977A290 Open, Classified |
LGW | None listed |
| Mar 25, 2021 | Medtronic Neuromodulation Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Open, Classified |
LGW | None listed |
| Nov 12, 2020 | Medtronic Neuromodulation Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtron Open, Classified |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage:
Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spin Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of ch Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of t Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500.
Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to th Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350.
Package Contents:
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/ Terminated |
LGW | None listed |
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