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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 NumberS041
Date Received05/23/2025
Decision Date08/21/2025
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 the addition of a Battery Pack Cup/Spacer to the Evoke Charger at the currently approved manufacturing site Integer-CCC (Montevideo, UY).
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