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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.
 
DeviceGENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS081
Date Received06/11/2014
Decision Date09/16/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MATERIAL CHANGE TO THE PORT PLUG USED IN THE APPROVED IMPLANTED PULSE GENERATORS (IPG MODELS 3608, 3688, 3716, 3788 AND 3789). THE PORT PLUG IS AN ACCESSORY TO THE IPG USED TO BLOCK TISSUE INGRESS INTO THE IPG HEADER. WHEN IMPLANTING ONLY A SINGLE LEAD IN AN IPG CONTAINING DUAL LEAD PORTS, THE PORT PLUG IS INSERTED INTO THE UNUSED LEAD PORT AND SECURED BY TIGHTENING THE SETSCREW ONTO THE PORT PLUG.
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