Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S051 · decided 2024-10-16
Approval details
- PMA number
- P130022
- Supplement
- S051
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-07-13
- Decision date
- 2024-10-16
- Days to decision
- 461 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- for an alternate supplier for components of the SURPASS Surgical Lead, moving the site in which manufacturing activities take place for the over mold process of a component, and change in the composition of a mold release agent
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