PMA P130028S022
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S022
- Product code
- LGW
- Decision date
- 2018-09-20
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for modifying the design of the Algovita Model 4200 Programmer Charger cable, and the Model 4230 Charging Paddle cable to improve the mechanical reliability (flex reliability) of the cables.
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S022
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-09-20
- Decision code
- APPR
- Date received
- 2018-06-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifying the design of the Algovita Model 4200 Programmer Charger cable, and the Model 4230 Charging Paddle cable to improve the mechanical reliability (flex reliability) of the cables.