Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
FDA premarket approval P130022/S044 · decided 2022-10-12
Approval details
- PMA number
- P130022
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2022-03-02
- Decision date
- 2022-10-12
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a new Implantable Pulse Generator (IPG) system called the Senza HFX iQ system. The Senza HFX iQ system includes the following devices:1) Bluetooth enabled IPG called the HFX iQ IPG (IPG3000);2) Updated Senza Bluetooth Trial Stimulator called the HFX Trial Stimulator (TSM3500);3) Updated compatible Bluetooth Patient Remote called the HFX iQ Remote (PTR3000);4) New mobile device application software called as the HFX iQ Patient Application (PTA); 5) Updated Clinician Programmer softwa
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.