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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.
 
DeviceWaveWriter Alpha™ Prime Spinal Cord Stimulation (SCS) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS389
Date Received09/25/2025
Decision Date12/10/2025
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha™ Prime Spinal Cord Stimulation and Vercise™ Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsulated within the IPG and ETS.
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