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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.
 
DeviceVercise Genus DBS System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS062
Date Received09/27/2023
Decision Date11/30/2023
Product Code NHL 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Your supplement requested approval for updates to the implanted pulse generator (IPG) firmware to delay time clock synchronization until charging is complete and replacing the capacitor C94, a 10 µF X7R capacitor, with a 22 µF X7R capacitor.
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