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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.
DeviceSpectra WaveWriter SCS System, WaveWriter 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 NumberS363
Date Received05/30/2023
Decision Date02/05/2024
Product Codes LGW QRB 
Docket Number 24M-0603
Notice Date 02/21/2024
Advisory Committee Neurology
Clinical TrialsNCT04676022
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of the treatment of chronic intractable low back and leg pain without prior back surgery in the Indications for Use statement for the Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, and WaveWriter Alpha Prime SCS System.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2