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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.
 
DevicePrecision Spinal Cord Stimulation (SCS) System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS288
Date Received03/14/2017
Decision Date06/01/2017
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for minor updates to the Printed Circuit Board Assembly (PCBA) of the Freelink Remote Control (Model SC-5250). Specifically, the update is to use a microcontroller from the same supplier with more flash memory and Random Access Memory (RAM). Because of the microcontroller memory size change, the device firmware is also updated.
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