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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, EONC, EON MINI PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPG'S)
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS105
Date Received10/08/2015
Decision Date11/06/2015
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ACCEPTANCE OF THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE IMPLANTABLE PULSE GENERATOR (IPG) WELD LEVEL SUB-ASSEMBLIES.
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