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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 NumberS044
Date Received09/13/2021
Decision Date10/07/2021
Product Code NHL 
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  
Update to the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to widen the acceptance criteria limits during the (PCBA) manufacturing process.
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