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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 NumberS019
Date Received09/22/2023
Decision Date03/20/2024
Product Codes LGW QRB 
Docket Number 24M-2534
Notice Date 05/24/2024
Advisory Committee Neurology
Clinical TrialsNCT04319887
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding the indications to include diabetic peripheral neuropathy of the lower extremities
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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