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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.
 
DeviceANS EON C (IPG) NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS021
Date Received07/13/2007
Decision Date12/10/2007
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE ANS EONC (IPG) NEUROMODULATION SYSTEM, MODEL 3688 WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMB, INCLUDING UNILATERAL AND BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND INTRACTABLE LOW BACK AND LEG PAIN.
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