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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 NumberS005
Date Received04/06/2023
Decision Date08/24/2023
Product Code QLK 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at 2159 India Street, San Diego, California 92101, for the manufacturing of the ReActiv8 Implantable Neurostimulation System.
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