Senza Spinal Cord Stimulation System (SCS)
FDA premarket approval P130022/S040 · decided 2021-05-10
Approval details
- PMA number
- P130022
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senza Spinal Cord Stimulation System (SCS)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2021-02-09
- Decision date
- 2021-05-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for MR conditional labeling for the Surpass-C surgical leads used with the Senza Spinal Cord Stimulation System
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