# LGW · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/LGW

## Overview

- **Product Code:** LGW
- **Device Name:** Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P190002S019](/device/P190002S019.md) | Saluda Medical Evoke® SCS System | Saluda Medical Pty, Ltd. | Mar 20, 2024 | APPR |
| [P030017S363](/device/P030017S363.md) | Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System | Boston Scientific Corp | Feb 5, 2024 | APPR |
| [P030017S357](/device/P030017S357.md) | Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A | Boston Scientific Corp | Oct 5, 2023 | APPR |
| [P010032S191](/device/P010032S191.md) | Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems | ABBOTT MEDICAL | May 10, 2023 | APPR |
| [P210037](/device/P210037.md) | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | Biotronik Nro, Inc. | Mar 31, 2023 | APPR |
| [P010032S189](/device/P010032S189.md) | Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems | ABBOTT MEDICAL | Jan 24, 2023 | APPR |
| [P190002](/device/P190002.md) | Saluda Medical Evoke SCS System | Saluda Medical Pty, Ltd. | Feb 28, 2022 | APPR |
| [P840001S469](/device/P840001S469.md) | Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St | Medtronic Neuromodulation | Jan 21, 2022 | APPR |
| [P130022S042](/device/P130022S042.md) | Senza Spinal Cord Stimulation (SCS) System | Nevro Corporation | Jan 18, 2022 | APPR |
| [P130022S039](/device/P130022S039.md) | Senza Spinal Cord Stimulation (SCS) System | Nevro Corporation | Jul 16, 2021 | APPR |
| [P030017S275](/device/P030017S275.md) | PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems | Boston Scientific Corp | Aug 11, 2017 | APPR |
| [P130028](/device/P130028.md) | ALGOVITA SPINAL CORD STIMULATION SYSTEM | Nuvectra Corporation | Nov 20, 2015 | APPR |
| [P130022](/device/P130022.md) | NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM | Nevro Corporation | May 8, 2015 | APPR |
| [P030017](/device/P030017.md) | PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM | Boston Scientific Corp | Apr 27, 2004 | APPR |
| [P010032](/device/P010032.md) | GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS | ABBOTT MEDICAL | Nov 21, 2001 | APPR |
| [P840001](/device/P840001.md) | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | Medtronic Neuromodulation | Nov 30, 1984 | APPR |
| [P800040](/device/P800040.md) | CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A, | Cordis Corp. | Apr 14, 1981 | APWD |

## Top Applicants

- Boston Scientific Corp — 4 clearances
- ABBOTT MEDICAL — 3 clearances
- Nevro Corporation — 3 clearances
- Medtronic Neuromodulation — 2 clearances
- Saluda Medical Pty, Ltd. — 2 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/LGW](https://fda-staging.innolitics.com/productcode/LGW)

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