Nevro Corp Senza® Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S054 · decided 2023-12-12
Approval details
- PMA number
- P130022
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nevro Corp Senza® Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-11-20
- Decision date
- 2023-12-12
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- approval to add a duplicate manufacturing line in the existing clean room to manufacture the same Senza System IPG3000 device as in the existing manufacturing line
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.