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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 NumberS397
Date Received06/12/2026
Decision Date07/10/2026
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  
to add a new controlled environment area (CEA) which is a Class 8 cleanroom, at the Boston Scientific Dorado, Puerto Rico facility for the manufacture of Boston Scientific Neuromodulation (BSN) Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) Products
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