PMA P190002S010

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S010
Product code: LGW
Decision date: 2022-08-03
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for modifications to software and firmware intended to reduce programming time in patients with significant evoked compound action potential (ECAP) artifact or negative ECAP values by adding the ClearCAP feature as well as minor labeling changes which include providing appropriate instructions for the new ClearCAP feature, updating the Evoke Pocket Console (EPC) product name to Evoke Patient Controller, and labelling updates required for commercialization.

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S010
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-08-03
Decision code: APPR
Date received: 2022-05-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifications to software and firmware intended to reduce programming time in patients with significant evoked compound action potential (ECAP) artifact or negative ECAP values by adding the ClearCAP feature as well as minor labeling changes which include providing appropriate instructions for the new ClearCAP feature, updating the Evoke Pocket Console (EPC) product name to Evoke Patient Controller, and labelling updates required for commercialization.