Senza spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S024 · decided 2019-12-18
Approval details
- PMA number
- P130022
- Supplement
- S024
- 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
- 2019-05-15
- Decision date
- 2019-12-18
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a new optional accessory tool - Nevro passing elevator accessory tool (PEAT) for use with Nevros Senza Spinal Cord Stimulation (SCS) System.
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