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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, Vercise Gevia DBS System, Vercise PC DBS System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS068
Date Received12/05/2023
Decision Date05/14/2024
Product Code NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
This updated software version only includes the enabling of the DBS Illumina 3D programming feature. All other VNN5 software functions and controls in place for programming the stimulation parameters into the implanted device and for delivering the stimulation via the implanted electrodes remain the same as the previously approved software version. The DBS Illumina 3D programming feature does not replace the need for clinical judgment in determining and finalizing the stimulation parameters that will be clinically effective for the patient, which remains the same as the previously approved software version. The device labeling has been updated with the following changes:- The VNN5 Programming Manual was updated to include the new VNN5 software version number and include instructions specific to the use of the DBS Illumina 3D programming feature.- The Clinician Programmer (CP) Software Installation Guide was updated to remove any specific mention of VNN5, thereby making the instructions more general to installing any software that will be used with the Clinician Programmer.- The DBS Reference Guide was updated to include the new VNN5 software version number and updating the document reference for the new CP Software Installation Guide.- A new Virtual Label was created for VNN5.0.1 to reflect the new software version number.
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