PMA P190002S049

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S049
Product code: LGW
Decision date: 2026-06-12
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: to transition to a new Ethylene Oxide (EO) sterilizer, add additional monitoring system to record temperature and pressure throughout cycle, improve control panel with touch screen digital panel, and add an alternate load configuration

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S049
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-06-12
Decision code: OK30
Date received: 2026-05-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to transition to a new Ethylene Oxide (EO) sterilizer, add additional monitoring system to record temperature and pressure throughout cycle, improve control panel with touch screen digital panel, and add an alternate load configuration