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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 NameGENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS081
Date Received06/18/2014
Decision Date09/16/2014
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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