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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 Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBiotronik Nro, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP210037
Supplement NumberS012
Date Received07/02/2025
Decision Date05/14/2026
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  
approval of a 20-in length version of the approved Tunnelling Tool (an accessory), with updated packaging, to the Prospera SCS System product family
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