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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 NumberS009
Date Received11/14/2024
Decision Date12/13/2024
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  
to update the routine microbiological (bioburden and endotoxin) testing for certain accessories to further align with ANSI/AAMI and ISO standards.
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