PMA P190002S039

Device: CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S039
Product code: LGW
Decision date: 2026-06-29
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for the CAP24 Paddle Lead and Passing Elevator components, software updates to the Clarity Clinical Programming Application (CPA) and RECAP Viewer (CDV) to support the CAP24 Paddle Lead and include minor bug fixes and improvements, and labeling updates to support these changes. Software changes required for use of the paddle lead with the Evoke Spinal Cord Stimulation (SCS) System were also approved in P190002/S038.

Current openFDA PMA Record#

Device: CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S039
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-06-29
Decision code: APPR
Date received: 2025-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the CAP24 Paddle Lead and Passing Elevator components, software updates to the Clarity Clinical Programming Application (CPA) and RECAP Viewer (CDV) to support the CAP24 Paddle Lead and include minor bug fixes and improvements, and labeling updates to support these changes. Software changes required for use of the paddle lead with the Evoke Spinal Cord Stimulation (SCS) System were also approved in P190002/S038.