# Saluda Medical Pty, Ltd.: PMA supplement approved for Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Saluda Medical Pty, Ltd. |
| Product | Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042) |
| Generic / ingredient | Stimulator, spinal-cord, totally implanted for pain relief |
| Approval | PMA supplement (device change) |
| Application | P190002 S038 |
| Decided | 2026-06-29 |
| Panel / class | Neurology |
| Sponsor location | Atarmon |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190002S038). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.