Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S033 · decided 2020-05-26
Approval details
- PMA number
- P130022
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2020-04-27
- Decision date
- 2020-05-26
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for adding B1+RMS scanner limits to support 1.5T Full Body MRI conditional labeling for IPG1000/1500/2000/2500 with Surpass surgical and Percutaneous leads to enhance the safety of the Senza SCS system. Also, you requested approval for some other minor additional administration clarifications added in the manual based on customer feedback on the readability of the manual.
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