# P130028: Algovita Spinal Cord Stimulation System

- Pathway: PMA
- Applicant: Nuvectra Corporation
- Decided: Nov 20, 2015 after 704 days
- Product code: LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief)
- Device class: 3
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 11, 2016 · Class II · Z-0781-2017: 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 
- Apr 6, 2016 · Class II · Z-1600-2016: 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 resul
- Jan 26, 2016 · Class II · Z-1193-2016: 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 foll
- Jan 26, 2016 · Class II · Z-1192-2016: 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 foll
- Jan 26, 2016 · Class II · Z-1194-2016: 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 foll

Source page: https://510kreport.com/device/P130028
Methodology: https://510kreport.com/methodology