PMA supplement
P130022 S044: Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
FDA PMA supplement · Normal 180 Day Track · Nevro Corporation
Key facts
| Original PMA | P130022 |
|---|---|
| Supplement number | S044 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | 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 |
| Product code | LGW |
| Received date | Mar 2, 2022 |
| Decision date | Oct 12, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: