PMA P130022S023
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S023
- Product code
- LGW
- Decision date
- 2019-07-18
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval to modify the patient remote cosmetically and to reduce the size; update the patient remote model numbers to PTR2300 and PTR2500; update the firmware for patient remote, model PTR2500 and the clinician programmer, model CLPG2000/CLPG2500 to support 5 stimulation therapy settings; and update the firmware to the IPG (renamed Omnia Senza IPG, Model NIPG2500) to support up to 5 stimulation settings.
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S023
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-07-18
- Decision code
- APPR
- Date received
- 2019-04-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the patient remote cosmetically and to reduce the size; update the patient remote model numbers to PTR2300 and PTR2500; update the firmware for patient remote, model PTR2500 and the clinician programmer, model CLPG2000/CLPG2500 to support 5 stimulation therapy settings; and update the firmware to the IPG (renamed Omnia Senza IPG, Model NIPG2500) to support up to 5 stimulation settings.