Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S041 · decided 2021-05-10
Approval details
- PMA number
- P130022
- Supplement
- S041
- 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
- 2021-02-12
- Decision date
- 2021-05-10
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a new 0.016 curved stylet with 22 degree band angle to be marketed with the Senza Spinal Cord Stimulation (SCS) System. This stylet will replace 0.012 curved stylet with 30 degree angle which is being discontinued.
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