PMA supplement
P240031 S005: Neuspera Sacral Neuromodulation (SNM) System
FDA PMA supplement · Real-Time Process · Neuspera Medical, Inc.
Key facts
| Original PMA | P240031 |
|---|---|
| Supplement number | S005 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Neuspera Sacral Neuromodulation (SNM) System |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Neuspera Medical, Inc. |
| Product code | EZW |
| Received date | Jun 1, 2026 |
| Decision date | Aug 21, 2026 |
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: