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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 NumberS017
Date Received06/01/2023
Decision Date12/03/2024
Product Code LGW 
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  
This is a 180-day supplement, which requested approval for updates of the programming software and stimulator firmware (Closed Loop Stimulator [CLS] and external Closed Loop Stimulator [eCLS]) of the Saluda Medical Evoke® Spinal Cord Stimulation (SCS) System to accommodate the addition of a new software module, the Assisted Programming Module (APM), within the Clarity Programming Application (CPA)
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