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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 SHEATHS
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP150004
Supplement NumberS004
Date Received07/21/2016
Decision Date08/18/2016
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  
Addition of an alternate supplier for a sub-assembly of the delivery sheaths used with the Axium Neurostimulator System.
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