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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 DBS System
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS003
Date Received01/17/2018
Decision Date04/24/2018
Product Code NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing sites located at Boston Scientific Limited, Cashel Road, Clonmel, Ireland (Vercise DBS IPG packaging, sterilization, and distribution operations); Guidant Puerto Rico B.V., No. 12, Road 698, Dorado, Puerto Rico (Vercise Leads, Extension, M8 Adaptor, and Physician’s Spare Kit manufacturing and sterilization operations); and Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, Minnesota (Vercise external devices and surgical accessories manufacturing and sterilization operations).
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