Spinal Cord Stimulation (SCS) Devices


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WHAT IS SCS? SCS PATIENT EXPERIENCE SCS DEVICES SCS FOR CHRONIC PAIN SCS VIDEOS


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)

Selected Manuals >>


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 >>

Selected Manuals >>


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

Selected Manuals >>


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)

Selected Manuals >>


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)

Selected Manuals >>


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)

Selected Manuals >>



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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