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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.
 
DeviceEON MINI, PRODIGY AND BRIO CHARGING SYSTEMS
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS126
Date Received11/01/2016
Decision Date12/01/2016
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Outsource the supply of an electronic wire component in the device assembly to a new supplier Carlisle Interconnect Technologies for various external devices with a change in the wire strip length at the tolerance level.
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