Spinal cord stimulation is regulated in the USA by the FDA. The information below summarizes FDA approvals for Spinal Cord Stimulation devices.
Medtronic
(some technology formerly Stimgenics, LLC)
Product name: Intellis™ Platform
FDA approval product code: LGW
Device Name in Originial FDA Approval: Intellis Spinal Cord Stimulation (SCS) Systems
Approval Type: PMA
Approval Number (Link to FDA site with Supplements): P840001
Original Date Approved: 11/30/1984
Most Recent Supplement / 510k: S479
Most Recent Supplement Approval Date: 12/23/2020
Additional Company / Product links >>
Some Available leads: Vectris™ SureScan™ MRI percutaneous leads (8 contacts), Specify™ SureScan™ MRI surgical leads (16 contacts)
Abbott Medical
(some technology formerly Advanded Neuromodulaiton Systems. Some technology formerly St. Jude Medical [Spinal Modulation, Inc.])
Product name: Proclaim™ XR, Proclaim™ Elite, Proclaim™ DRG Neurostimulator System, Prodigy MRI™
FDA approval product code: LGW (Genesis and Eon Family Neurostimulation (IPG) Systems), PMP(Axium Neurostimulator System)
| Device Name in Originial FDA Approval: | Genesis and Eon Family Neurostimulation (IPG) Systems |
|---|---|
| Approval Type (Link to FDA letter): | PMA |
| Approval Number (Link to FDA site with Supplements): | P010032 |
| Original Date Approved: | 11/16/2001 |
| Most Recent Supplement / 510k: | S167 |
| Most Recent Supplement Approval Date: | 08/18/2020 |
Additional Company / Product links >>
| Device Name in Originial FDA Approval: | Axium Neurostimulator System |
|---|---|
| Approval Type (Link to FDA letter): | PMA |
| Approval Number (Link to FDA site with Supplements): | P150004 |
| Original Date Approved: | 02/11/2016 |
| Most Recent Supplement / 510k: | S042 |
| Most Recent Supplement Approval Date: | 08/18/2020 |
| Some Available leads: | Tripole (16 contacts), Lamitrode™ Exclaim™ leads (8 contacts), 3186 Octrode™ lead (8 contacts), 3228 Penta™ lead (20 contacts) Paddle Leads & Percutaneous Leads |
Additional Company / Product links >>
Boston Scientific
Product name: Precision Spectra™, Spectra™ Plus, Spectra WaveWriter™, Precision Novi™, Precision Montage™ MRI
FDA approval product code: LGW
Device Name in Originial FDA Approval: Precision Spinal Cord Stimulation (SCS) Systems
Approval Type (Link to FDA letter): PMA
Approval Number (Link to FDA site with Supplements): P030017
Original Date Approved: 3/15/2004
Most Recent Supplement / 510k: S338
Most Recent Supplement Approval Date: 12/01/2020
Additional Company / Product links >>
Some Available leads:CoverEdge™ & CoverEdge X 32 Surgical Leads (32 contacts), Linear ST xxcm (8 contacts), Avista™ MRI Lead (8 contacts) SCS Lead Portfolio Lead Adapters
Nevro
Product name: "Senza® Omnia™ SCS System, The Senza® System, Senza II™ System"
FDA approval product code: LGW
Device Name in Originial FDA Approval:Nevro Senza Spinal Cord Stimulation (SCS) System
Approval Type (Link to FDA letter):PMA
Approval Number (Link to FDA site with Supplements): P130022
Original Date Approved: 5/8/15
Most Recent Supplement / 510k: S033
Most Recent Supplement Approval Date: 05/26/2020
Additional Company / Product links >>
Some Available leads:Surpass™ Surgical Lead (8 Contacts)
Nuvectra*
(some technology formerly Cirtec Medical)
Product name:Algovita™ Spinal Cord Stimulation System
FDA approval product code:< LGW
Device Name in Originial FDA Approval: Algovita Spinal Cord Stimulation (SCS) System
Approval Type (Link to FDA letter): PMA
Approval Number (Link to FDA site with Supplements): P130028
Original Date Approved: 11/20/2015
Most Recent Supplement / 510k: S031
Most Recent Supplement Approval Date: 05/05/2020
Additional Company / Product links >>
Some Available leads: Vectris™ SureScan™ MRI percutaneous leads (8 contacts), Specify™ SureScan™ MRI surgical leads (16 contacts)
Nalu Medical
Product name: Nalu Neurostimulation SCS System
FDA approval product code: GZB
Device Name in Originial FDA Approval: Nalu Neurostimulation SCS System
Approval Type (Link to FDA letter): 510(K)
Approval Number (Link to FDA site with Supplements): K183047
Original Date Approved: 03/22/2019
Most Recent Supplement / 510k: K202274
Most Recent Supplement Approval Date: 11/09/2020
Additional Company / Product links >>
Some Available leads: Nalu Neurostimulation Leads (8 Contacts)
Mainstay Medical Limited
Product name:ReActiv8 Implantable Neurostimulation System
FDA approval product code: QLK
Device Name in Originial FDA Approval: ReActiv8 Implantable Neurostimulation System
Approval Type (Link to FDA letter):PMA
Approval Number (Link to FDA site with Supplements): P190021
Original Date Approved:06/22/2020
Most Recent Supplement / 510k: N/A
Most Recent Supplement Approval Date: N/A
Additional Company / Product links >>
Some Available leads: Model 8145 and Model 8165 ReActiv8 Implantable Stimulation Percutaneous Leads (4 contacts)
This table is limited to product with one or more US FDA approvals. This table was last updated on 1/03/2020 This is provided for non-commercial purposes and no claims are made about the accuracy of this. This is not medical advice.
Aquisitions (formally) focus on those reflected in regulatory FDA filings.
The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Medically reviewed by Corey W Hunter, MD, FIPP - Ainsworth Institute of Pain Management and Mt Sinai Hospital
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