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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 S8 Adapter
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Supplement NumberS055
Date Received03/17/2023
Decision Date09/06/2023
Product Code NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Vercise Adapter S8 and the addition of the use with Abbott Lead models (6170, 6171, 6172, 6173, 6178, 6179, 6180, and 6181) to the Vercise Neural Navigator 5 (VNN5) software.
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