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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 PC Deep and Vercise Geviarn Deep Brain Stimulation (DBS) Systems
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS013
Date Received02/12/2019
Decision Date03/13/2019
Product Code NHL 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Automated tool used in the manufacturing of the Stack Assembly, a subassembly component inside the header of Implantable Pulse Generators (IPGs) of the Vercise PC and Vercise Gevia DBS systems.
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