Senza Spinal Cord Stimulation (SCS) System
FDA premarket approval P130022/S053 · decided 2024-04-10
Approval details
- PMA number
- P130022
- Supplement
- S053
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza Spinal Cord Stimulation (SCS) System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-10-26
- Decision date
- 2024-04-10
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- implementation of a manufacturing process change to the welds of the battery components of the IPG
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.