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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.
 
DevicePrecision Spinal Cord Stimulator (SCS) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS386
Date Received08/22/2025
Decision Date09/19/2025
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the qualification of an alternate supplier, AVNA, for the IPG Pocket Template used with the Boston Scientific Neuromodulation Spinal Cord Stimulator and Deep Brain Stimulation Implantable Pulse Generators (IPGs). Additionally, the alternate supplier is changing the manufacturing process for the IPG Pocket Templates from chemical etching to metal stamping and laser etching
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