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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEON NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS059
Date Received07/17/2012
Decision Date01/09/2013
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval the revision to the manufacturing process for eon mini (model 3788) implantable pulse generator headers.
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