PMA P190002S013

Device: Saluda Medical Evoke® SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S013
Product code: LGW
Decision date: 2022-12-15
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for design changes to the set screw and set screw block components of the lead extension, including an increase in set screw block inner diameter, increase in thread size of the set screw and set screw block hole, and other minor changes in geometry.

Current openFDA PMA Record#

Device: Saluda Medical Evoke® SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S013
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-12-15
Decision code: APPR
Date received: 2022-09-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design changes to the set screw and set screw block components of the lead extension, including an increase in set screw block inner diameter, increase in thread size of the set screw and set screw block hole, and other minor changes in geometry.