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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 Deep Brain Stimulation System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS080
Date Received12/05/2024
Decision Date12/23/2024
Product Code NHL 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The supplement was submitted as a part of an advisory issued in August 2024. The labeling change is to add the following warning to the ''Implanting the IPG'' Section (Step 15) of the Surgical Implant Manual:''Submuscular implant in the pectoral region (i.e. subpectoral) may expose the Vercise Genus rechargeable IPG to frequent muscle tension forces which may cause component damage (feedthrough wire(s)) resulting in device malfunction that could lead to adverse events including explant of the IPG”
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