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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.
 
DeviceProspera SCS System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBiotronik Nro, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP210037
Supplement NumberS004
Date Received01/25/2024
Decision Date08/23/2024
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
Approval Order Statement  
the change in manufacturer for the inductive telemetry coil communication unit (CU) component of the Prospera Implantable Pulse Generator (IPG) and External Pulse Generator (EPG).
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