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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantSaluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064
PMA NumberP190002
Supplement NumberS039
Date Received04/01/2025
Decision Date06/29/2026
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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