Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S036 · decided 2021-03-06
Approval details
- PMA number
- P130022
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- 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
- 2020-08-19
- Decision date
- 2021-03-06
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the Senza Bluetooth Trial system which consists of the following components: Bluetooth Trial Stimulator (TSM), Bluetooth Patient Remote (PTR), and Updated Clinician Programmer Software (PS). Accessory kits that support the Senza Bluetooth Trial system consist of the Trial Stimulator Pouch kit, Extra battery kit and the Magnet kit.
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