Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System
FDA premarket approval P130022/S047 · decided 2022-12-23
Approval details
- PMA number
- P130022
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2022-11-22
- Decision date
- 2022-12-23
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Add an alternate manufacturing site, the NevroCosta Rica (CR) facility, for the HFX Trial Stimulator (TSM3500) and to add an alternate Printed Circuit Board Assembly (PCBA) supplier, Micro Systems Engineering, Inc. (MSEI), for the HFX Trial Stimulator (TSM3500).
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