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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; Resilience Percutaneous Lead; Embrace One; TrueLock
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBiotronik Nro, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP210037
Supplement NumberS013
Date Received09/23/2025
Decision Date10/23/2025
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternative supplier, Unisteel, for the set screw component used to fix the connector pin of an inserted lead in the ports of the Prospera IPG (Part Number 338566)
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