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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.
 
DeviceAxium Neurostimulator System
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP150004
Supplement NumberS001
Date Received03/11/2016
Decision Date05/26/2016
Product Code PMP 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the post-approval study protocol.
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