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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
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS045
Date Received09/29/2021
Decision Date03/24/2022
Product Code NHL 
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 to labeling change to add the Medtronic Leads, Extensions, Lead Accessories and the BSN M8 Adaptor to the list of devices that are Magnetic resonance imaging (MRI) scan eligible for the Vercise Genus DBS System. There is no change to the MRI radiology conditions of use or any other implant conditions of use compared to those approved for the Vercise Genus DBS System.
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