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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.
 
DeviceEonC and Eon Mini Neurostimulation System
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS135
Date Received09/12/2017
Decision Date12/09/2017
Product Code LGW 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for enabling the BurstDR™ stimulation feature on the already-implanted Eon family devices (two models: EonC and Eon Mini) for a short evaluation period (30 days).
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