ClearanceBrief
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)
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Top companies in LGW

DateFirm and productCodeLinked 510(k)
Aug 5, 2026Boston 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
LGWNone listed
Jun 11, 2026Boston Scientific Neuromodulation Corporation
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Open, Classified
LGWNone 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
Nov 7, 2025Abbott Medical
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Open, Classified
LGWNone 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
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 17, 2024Medtronic Neuromodulation
Vanta Implantable Neurostimulator (INS), Model 977006
Open, Classified
LGWNone listed
Aug 14, 2024Boston Scientific Neuromodulation Corporation
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Open, Classified
LGWNone listed
Jul 16, 2024Abbott Medical
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Open, Classified
LGWNone 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
Nov 20, 2023Medtronic Neuromodulation
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Open, Classified
LGWNone listed
Sep 29, 2023Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Terminated
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone listed
Sep 11, 2023Abbott 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
LGWNone 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
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
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
Jul 9, 2021Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Open, Classified
LGWNone listed
Mar 25, 2021Medtronic 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
LGWNone listed
Nov 12, 2020Medtronic 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
LGWNone listed
Apr 24, 2019Boston 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
LGWNone listed
Apr 24, 2019Boston 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
LGWNone listed
Apr 24, 2019Boston 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
LGWNone listed
Apr 24, 2019Boston 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
LGWNone listed
Apr 24, 2019Boston 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
LGWNone listed

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