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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
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantSaluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064
PMA NumberP190002
Supplement NumberS010
Date Received05/09/2022
Decision Date08/03/2022
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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