BCIwiki (bciwiki.com) — The U.S. Food and Drug Administration (FDA) approved a PMA supplement (S039) to Saluda Medical Pty, Ltd. on June 29, 2026, covering the CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer. The supplement was a normal 180-day track labeling change involving indications, instructions, shelf life, and trade name. The device's generic name is Stimulator, spinal-cord, totally implanted for pain relief.
This approval is a supplement under the Premarket Approval (PMA) pathway, not an original approval of a new device. PMA is the FDA pathway for Class III devices; implantable BCI and neuromodulation devices typically go through PMA or De Novo, not 510(k). Saluda Medical's Evoke system is a closed-loop spinal cord stimulator, and this labeling change may involve updates to product identification and clinical use instructions.