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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 Genus™ 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 NumberS046
Date Received10/12/2021
Decision Date11/10/2021
Product Code NHL 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use VLSIP Technologies as an alternate supplier for the Ball Grid Array (BGA), an electronic component on the Printed Circuit Board Assembly (PCBA) of the Implantable Pulse Generators (IPG) and External Trial Stimulators (ETS) of the WaveWriter Alpha Spinal Cord Stimulator (SCS) System and Vercise Genus Deep Brain Stimulation (DBS) System.
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