PMA · Approved
Recalled · Class II · 2016Algovita Spinal Cord Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvectra Corporation · LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Approved on Nov 20, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 704-day review. It has been recalled 5 times.
- Decided
- Nov 20, 2015
- Review
- 704 days
- Class
- Class III
- Product code
- LGW
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P130028 has 30 supplements since 2015: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2015 | 1 |
| 2016 | 11 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 7 |
| 2020 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2016 | Class II | Z-0781-2017 | Nonconforming Material/Component | 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… |
| Apr 6, 2016 | Class II | Z-1600-2016 | Software design | 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… |
| Jan 26, 2016 | Class II | Z-1193-2016 | Nonconforming Material/Component | 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… |
| Jan 26, 2016 | Class II | Z-1192-2016 | Nonconforming Material/Component | 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… |
| Jan 26, 2016 | Class II | Z-1194-2016 | Nonconforming Material/Component | 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… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LGW devicesLGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LGW
65in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGW
Too few LGW 510(k)s in any year since 2007 to give a median.
Recalls per year · LGW
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LGW
31,054in 2025
MAUDE reports naming product code LGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | — | 4 | 1,094 |
| 2008 | 53 | — | 4 | 3,018 |
| 2009 | 38 | — | 2 | 5,251 |
| 2010 | 56 | — | 2 | 9,265 |
| 2011 | 47 | — | 1 | 11,132 |
| 2012 | 68 | — | 1 | 17,915 |
| 2013 | 71 | — | 3 | 22,432 |
| 2014 | 68 | — | 0 | 11,250 |
| 2015 | 72 | — | 0 | 11,690 |
| 2016 | 92 | — | 2 | 15,643 |
| 2017 | 94 | — | 2 | 18,612 |
| 2018 | 64 | — | 0 | 23,626 |
| 2019 | 69 | — | 0 | 30,038 |
| 2020 | 52 | — | 1 | 28,106 |
| 2021 | 56 | — | 1 | 24,333 |
| 2022 | 60 | — | 5 | 23,269 |
| 2023 | 63 | — | 2 | 33,528 |
| 2024 | 94 | — | 2 | 35,074 |
| 2025 | 65 | — | 3 | 31,054 |
| 2026 | 56 | — | 2 (1) | — |
https://510kreport.com/device/P130028 · printed Nov 6, 2026
Cite this page
510(k) Report. “P130028: Algovita Spinal Cord Stimulation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P130028
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026