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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 NumberS003
Date Received01/13/2023
Decision Date06/23/2023
Product Code QLK 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in manufacturing layout for the ReActiv8® Implantable Neurostimulation System to introduce improvements in the distribution of the Surface Mount Technology (SMT) manufacturing area and expand capacity to meet increasing volume of business.
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