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Algovita Spinal Cord Stimulation System

by Nuvectra Corporation PMA

Active United States

PMA P130028

Overview

The Algovita Spinal Cord Stimulation System is a Stimulator, Spinal-Cord, Totally Implanted for Pain Relief, designed to modulate nerve signals to alleviate chronic intractable pain in the trunk and limbs. This device is intended for patients experiencing unilateral or bilateral pain associated with conditions such as Failed Back Surgery Syndrome, intractable low back pain, and leg pain.

The system is implanted surgically and is intended for long-term use. It is regulated under FDA_PMA with approval number P130028 and falls under product code LGW. The device is not described as single-use or reusable in the specifications, nor are MRI safety or sterility details provided. Storage and handling instructions are not specified in the provided data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP130028 Date20 Nov 2015ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

5 recalls · FDA

    • Terminated Z-0781-2017 FDA Class II initiated 11 Oct 2016

    Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.

    • Terminated Z-1600-2016 FDA Class II initiated 6 Apr 2016

    If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.

  • 3 recalls, same reason

    • Terminated Z-1192-2016 FDA Class II initiated 26 Jan 2016
    • Terminated Z-1194-2016 FDA Class II initiated 26 Jan 2016
    • Terminated Z-1193-2016 FDA Class II initiated 26 Jan 2016

    The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.

Specification

PMA

Generic Name
Stimulator, spinal-cord, totally implanted for pain relief
PMA Number
FDA Product Code
LGW
Device Class
Class III
Advisory Committee
Neurology
FDA Decision
APPR Approved