PMA P130022S027
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S027
- Product code
- LGW
- Decision date
- 2019-11-08
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for mechanical and design changes made to the current charger (CGR1000) for the Senza Spinal Cord Stimulation (SCS) system to improve cosmetics and reduce the size of the charger. The modified patient remote charger will now be offered as model CGR2500.
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S027
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-11-08
- Decision code
- APPR
- Date received
- 2019-08-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for mechanical and design changes made to the current charger (CGR1000) for the Senza Spinal Cord Stimulation (SCS) system to improve cosmetics and reduce the size of the charger. The modified patient remote charger will now be offered as model CGR2500.