Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S055 · decided 2024-02-21
Approval details
- PMA number
- P130022
- Supplement
- S055
- Supplement type
- 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
- 2024-01-25
- Decision date
- 2024-02-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- a manufacturing process change (consolidation of skiving, etching and cleaning process steps) performed by a sub-tier supplier for the multi-lumen tubing used for manufacturing leads, lead extensions and lead adaptors used as part of the Senza SCS System
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