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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 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 NumberS028
Date Received12/30/2019
Decision Date12/29/2020
Product Code NHL 
Docket Number 20M-2367
Notice Date 01/27/2021
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Vercise PC and Vercise Gevia DBS Systems for expanding the indications to include bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that is not adequately controlled by medications.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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