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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 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 NumberS006
Date Received05/21/2018
Decision Date06/19/2018
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  
Additional Ethylene Oxide (EO) sterilization chamber (Getinge Gl) and associated sterilization process located at Boston Scientific Dorado manufacturing site (BSC-DOR) for routine sterilization of the Lead products (Lead, Lead Extension, Adapter and Physician's Spare Kit) of the Vercise Deep Brain Stimulation (DBS) System
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