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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.
 
DeviceEON NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS055
Date Received06/06/2012
Decision Date10/25/2012
Product Code LGW 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY.
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