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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.
 
DeviceSaluda Medical Evoke SCS System; Closed Loop Stimulator (CLS) (REF: 3042)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantSaluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064
PMA NumberP190002
Supplement NumberS038
Date Received03/21/2025
Decision Date06/29/2026
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
updated firmware configuration (Therapy Firmware Th 6.4.1.0; Telemetry Firmware Te 4.3.5.0) for the Evoke® implanted closed loop stimulator (CLS) (REF: 3042)
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