Nevro Corp Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S045 · decided 2023-01-27
Approval details
- PMA number
- P130022
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nevro Corp Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2022-04-08
- Decision date
- 2023-01-27
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for use of an alternate Contego 440 proposed battery component for the IPG2500 device of the Senza System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.