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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 NumberS384
Date Received05/27/2025
Decision Date06/25/2025
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  
approval for an alternate Sterilization Cycle (BSC120), to sterilize all Deep Brain Stimulation (DBS) and Spinal Cord Stimulator (SCS) Implantable Pulse Generators (IPGs) manufactured at the BSC Clonmel (CLN) site, County Tipperary, Ireland
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