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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 IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantADVANCED NEUROMODULATION SYSTEMS (ANS)
PMA NumberP010032
Supplement NumberS032
Date Received07/15/2009
Decision Date04/08/2010
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the incorporation of a color additive to change the color of the pocket sizer to yellow, so that it would be more easily visible to the physician.
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