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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 NumberS084
Date Received04/03/2025
Decision Date09/13/2026
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
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 MRI guidelines labeling updates to include the Vercise Cartesia X and HX 16-contact Directional Leads, 16-contact Lead Extensions, and 8x2-contact Lead extensions of the Vercise Genus DBS System to the configurations approved for 1.5T MRI scans.
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