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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 NumberS008
Date Received11/14/2024
Decision Date12/12/2024
Product Code QLK 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate 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 modifications to labeling related to two separate updates, clarification regarding the allowable receive coils compatible with the system’s Magnetic Resonance (MR) conditional labelling and refinement of the considerations for patient selection
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