PMA P190002S009

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S009
Product code: LGW
Decision date: 2022-07-26
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for updated kit configurations for the Percutaneous Lead Kit, Trial Lead Kit, and Spares Kit, addition of the new Active Anchor Kit, updated shelf-life from one to two years, and minor labeling changes.

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S009
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-07-26
Decision code: APPR
Date received: 2022-04-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updated kit configurations for the Percutaneous Lead Kit, Trial Lead Kit, and Spares Kit, addition of the new Active Anchor Kit, updated shelf-life from one to two years, and minor labeling changes.