Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S018 · decided 2018-10-21
Approval details
- PMA number
- P130022
- Supplement
- S018
- 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
- 2018-07-23
- Decision date
- 2018-10-21
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for changing the length and shape of the handle, and the method of securing the cap and wire to the handle of the Stylets distributed with the Senza Spinal Cord Stimulation System
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