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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 and Vercise Gevia Deep Brain Stimulation (DBS) System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS015
Date Received02/19/2019
Decision Date03/19/2019
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  
Adding an alternate qualified supplier (Heraeus) for the cables used in the Deep Brain Stimulation (DBS) Leads, which include the standard DBS Leads and the Vercise Cartesia DBS Directional Leads.
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