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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 Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS374
Date Received04/02/2024
Decision Date12/18/2025
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) labeling updates to the WaveWriter Alpha Spinal Cord Stimulator (SCS) MRI Safety Guidelines to allow for Bl+rms limits to be set as the primary limiting condition for RF power, 2) a labeling update to the MRI Safety Guidelines and Precision Adapter M8 Instructions for Use to add the Medtronic Specify SureScan MRI Leads to the list of leads compatible with the BSN M8 Adapter as part of the WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, and 3) the WaveWriter Alpha SCS Mixed System using the Medtronic Specify SureScan leads will be labeled as MRI scan eligible.
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