PMA P130022S026
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S026
- Product code
- LGW
- Decision date
- 2019-10-25
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval to make changes to the software for the Clinical Programmer, model CLPG2000/CLPG2500 upgrading the software from version 1.7 to 2.0.
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S026
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-10-25
- Decision code
- APPR
- Date received
- 2019-07-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to make changes to the software for the Clinical Programmer, model CLPG2000/CLPG2500 upgrading the software from version 1.7 to 2.0.