Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S023 · decided 2019-07-18
Approval details
- PMA number
- P130022
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2019-04-19
- Decision date
- 2019-07-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.