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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.
 
DeviceSCS EPG Header
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS147
Date Received12/26/2018
Decision Date03/26/2019
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 design changes including increasing the thickness of the polyimide substrate and decreasing the thickness of the polyimide coverfilm on the Flex Printed Circuit Board (PCB) on the Spinal Cord Stimulation External Pulse Generator (SCS EPG) header, model 3032.
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