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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™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS396
Date Received06/11/2026
Decision Date09/09/2026
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the removal of the precaution statement related to subperception therapy in the “Information for Prescribers” and “Information for Patients” user manuals for the WaveWriter Alpha, WaveWriter Alpha Prime, Celestia, and Celestia Prime Spinal Cord Stimulation (SCS) Systems.
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