PMA
P190002: Saluda Medical Evoke SCS System
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Saluda Medical Pty, Ltd.
Key facts
| PMA number | P190002 |
|---|---|
| Trade name | Saluda Medical Evoke SCS System |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Saluda Medical Pty, Ltd. |
| Owner/operator | Saluda Medical Pty Ltd |
| Product code | LGW |
| Approval date | Feb 28, 2022 |
| Docket number | 22M-0279 |
| Notice date | Mar 4, 2022 |
| Establishment registration | 3016111136 |
| FEI number | 3016111136 |
At a glance
- 10–99 Supplements
- Jun 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: