Senza® HFX iQ System
FDA premarket approval P130022/S067 · decided 2025-08-15
Approval details
- PMA number
- P130022
- Supplement
- S067
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Senza® HFX iQ System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2024-12-20
- Decision date
- 2025-08-15
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for changes to the printed circuit board assembly (PCBA) board used in IPG3000, including replacing the microcontroller from rev 2 to rev 3, replacing the fuel gauge with a battery voltage measurement circuit, changing the material of the printed circuit board (PCB), moving the PCBA battery fuse from the negative terminal to the positive terminal, other minor modifications to PCB layout (reorganizing components and modification of solder pad size), as well as an alternate PCBA supplier
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