PMA P130022S018
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S018
- Product code
- LGW
- Decision date
- 2018-10-21
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for changing the length and shape of the handle, and the method of securing the cap and wire to the handle of the Stylets distributed with the Senza Spinal Cord Stimulation System
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S018
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-10-21
- Decision code
- APPR
- Date received
- 2018-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changing the length and shape of the handle, and the method of securing the cap and wire to the handle of the Stylets distributed with the Senza Spinal Cord Stimulation System