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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 SCS System, WaveWriter Alpha Prime SCS System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS381
Date Received12/20/2024
Decision Date03/17/2025
Product Codes LGW QRB 
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  
Approval of PMA 180-day supplement, which requested approval for adding 3T Magnetic Resonance (MR) conditional labeling to the implanted components of the WaveWriter Alpha Spinal Cord Stimulation (SCS) System and WaveWriter Alpha Prime SCS System for head and lower extremities
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