PMA P190002S038

Device: Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S038
Product code: LGW
Decision date: 2026-06-29
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: updated firmware configuration (Therapy Firmware Th 6.4.1.0; Telemetry Firmware Te 4.3.5.0) for the Evoke® implanted closed loop stimulator (CLS) (REF: 3042)

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S038
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-06-29
Decision code: APPR
Date received: 2025-03-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: updated firmware configuration (Therapy Firmware Th 6.4.1.0; Telemetry Firmware Te 4.3.5.0) for the Evoke® implanted closed loop stimulator (CLS) (REF: 3042)