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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, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS039
Date Received01/29/2021
Decision Date11/15/2021
Product Code NHL 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to add alternate suppliers for the patient contacting components of the SureTek Burr Hole Cover Kits, used during the deep brain stimulation (DBS) process, for the Vercise, Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems
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