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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 MINI IPG NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS058
Date Received07/16/2012
Decision Date09/14/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification to the model 3721 eon mini charging system. The device, as modified, will be marketed under the trade name model 3720 eon mini le charger and model 3722 eon mini le charging system and is indicated as an aid in the management of chronic pain of the trunk and/or limbs, including unilateral pain associated with any of the following: failed back surgery syndrome, and chronic low back/leg pain.
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