Nevro Corp Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S061 · decided 2025-06-30
Approval details
- PMA number
- P130022
- Supplement
- S061
- Supplement type
- Normal 180 Day Track
- 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
- 2024-09-03
- Decision date
- 2025-06-30
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- approval for the addition of alternate suppliers to the feedthrough (i.e., Integer Tijuana) and titanium case (i.e., Greatbatch Medical) components of the implantable pulse generator (IPG) used in the Senza SCS System, and approval for minor changes made to the feedthrough to improve manufacturability and yield of this component and additional reference specifications that were added for the titanium case for better manufacturability
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