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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received01/22/2019
Decision Date02/28/2022
Product Code LGW 
Docket Number 22M-0279
Notice Date 03/04/2022
Advisory Committee Neurology
Clinical TrialsNCT02924129
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Evoke® SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbsincluding unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S016 S008 S009 S010 S011 S014 S015 S045 S017 S034 S036  
S018 S019 S020 S001 S002 S003 S004 S005 S006 S007 S012 S013 
S030 S031 S032 S033 S028 S021 S022 S023 S041 S043 S037 S024 
S025 S026 S027 
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