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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.
 
DeviceModel A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta™/Sequentia™ LT Clinician Programmer A
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS594
Date Received04/30/2025
Decision Date07/29/2025
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for changes to Model A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta™/Sequentia™ LT Clinician Programmer Application (CPA) to correct known software anomalies.
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