Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System
FDA premarket approval P130022/S056 · decided 2024-05-29
Approval details
- PMA number
- P130022
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2024-02-29
- Decision date
- 2024-05-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- software changes to the following components of the Senza HFX iQ System: Bluetooth Implantable Pulse Generator (IPG3000), HFX Trial Stimulator (TSM3500), HFX Application (iOS) (PTA10043), Clinical Programmer Software (CLPG2000/2500).
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