PMA supplement
P180046 S078: Axonics Sacral Neuromodulation System
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corporation
Key facts
| Original PMA | P180046 |
|---|---|
| Supplement number | S078 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Axonics Sacral Neuromodulation System |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Boston Scientific Corporation |
| Product code | EZW |
| Received date | Jan 25, 2024 |
| Decision date | Aug 2, 2024 |
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: