PMA P190002S005

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
Product code: LGW
Decision date: 2022-07-06
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for design changes to the lead and stylet used with the Evoke Spinal Cord Stimulation (SCS) System, including decreasing the stylet length by 14mm and removing the epoxy material surrounding the non-active band at the proximal end of the lead.

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S005
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-07-06
Decision code: APPR
Date received: 2022-04-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design changes to the lead and stylet used with the Evoke Spinal Cord Stimulation (SCS) System, including decreasing the stylet length by 14mm and removing the epoxy material surrounding the non-active band at the proximal end of the lead.