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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.
 
DeviceReActiv8 Implantable Neurostimulation System
Generic NameStimulator, neuromuscular, lower back muscles, totally implanted for pain relief
ApplicantMainstay Medical Limited
Clonmel House Forster Way
Swords, Co Dublin K67F2K3
PMA NumberP190021
Supplement NumberS009
Date Received03/25/2025
Decision Date06/20/2025
Product Code QLK 
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  
approval for labeling updates for the Mainstay ReActiv8 System including: 1) inclusion of 5-year follow-up clinical data in the “Clinical Summary” manual and 2) updates to risks in the “Implant and Programming” manual and the “User Manual”.
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