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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) Systems
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS057
Date Received05/04/2023
Decision Date05/12/2023
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  
Remove the Verify Multi-lumen Tube Length step currently performed at the BSC Dorado manufacturing site during the assembly of the 15cm Precision M8 Adapter, Precision M8 Trial Adapter, and Vercise M8 Adapter of the Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) systems.
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