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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.
 
DevicemySCS™ GO Therapy Controller App
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS358
Date Received12/28/2022
Decision Date04/04/2024
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a mobile application referred to as the mySCSTM GO Therapy Controller App. The mySCSTM GO Therapy Controller App will be used on an off-the-shelf mobile phone and functions as an alternate to the current FreelinkTM Remote Control (RC) to control the WaveWriter Alpha IPG and External Trial Stimulator (ETS) Systems (P030017/S338).
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