| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Nevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065 |
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| PMA Number | P130022 |
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| Supplement Number | S044 |
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| Date Received | 03/02/2022 |
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| Decision Date | 10/12/2022 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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 software to configure the Bluetooth Trial Stimulators and Bluetooth IPG; and6) New software called as Gaea Cryptofunction that implements certain cybersecurity features of the Senza HFX iQ system. |
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