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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.
 
DevicePROTEGE NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS079
Date Received04/15/2014
Decision Date07/14/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR RAPID PROGRAMMER VERSION 3.6 TO SUPPORT THEPROGRAMMING OF THE PROTÉGÉ NEUROSTIMULATION DEVICES (MODEL 3789 PROTÉGÉ IMPLANTABLE PULSE GENERATOR AND MODEL 3852 PATIENT PROGRAMMER) AS WELL AS TO MAKE MINOR SUSTAINING ENHANCEMENTS.
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