PMA P130028S015
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S015
- Product code
- LGW
- Decision date
- 2017-03-31
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Changes to the Implantable Pulse Generator printed circuit board (PCB) functional test system software in order to improve system reliability and to better conform to device performance specifications.
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S015
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-03-31
- Decision code
- OK30
- Date received
- 2017-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the Implantable Pulse Generator printed circuit board (PCB) functional test system software in order to improve system reliability and to better conform to device performance specifications.