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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 NumberS031
Date Received07/01/2019
Decision Date07/29/2019
Product Code PMP 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Move FMI manufacturing operations from its current site at Elk Grove Village, Illinois, USA to a facility in Lincolnshire, Illinois, USA. FMI is the currently approved supplier for molded silicone parts that go into the finished assembly and packaging of implantable pulse generators (IPGs), leads, lead extensions, lead adapters, and lead accessories.
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