Senza HFX iQ System
FDA premarket approval P130022/S068 · decided 2025-03-28
Approval details
- PMA number
- P130022
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senza HFX iQ System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2025-02-27
- Decision date
- 2025-03-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- for process change for sterilizing Senza system leads (LEAD1058, TLEAD1058, LEAD2005, LEAD3005)
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