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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 NumberS065
Date Received09/29/2023
Decision Date11/13/2024
Product Code NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
which requested approval for the following:• Vercise Cartesia X Directional Lead Kits (Models DB-2203-30B and DB-2203-45B), • Vercise Cartesia HX 16-contact Directional Lead Kits (Models DB-2204-30B and DB-2204-45B), • 16-contact Lead Extension Kits (Models DB-3216-55 and DB-3216-95), • 2x8 Lead Extension Kits (Models DB-3128 and DB-3128-95), and • Vercise Physician’s Spare Kit (Model DB-2501).
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