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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 Deep Brain Stimulation (DBS) System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS066
Date Received10/26/2023
Decision Date01/10/2024
Product Code NHL 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for MR Conditional status of the following three configurations for use with two Boston Scientific Vercise Genus Implanted Pulse Generators (IPG): Boston Scientific Leads, One IPG with Boston Scientific Lead and One IPG with Medtronic Lead (with M8 Lead Adapter), and Medtronic Leads (with M8 Lead Adapters)
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