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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.
 
DeviceProclaim SCS Neurostimulation System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS166
Date Received07/14/2020
Decision Date01/19/2021
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement.
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