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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™, Precision Spectra™, Precision Novi™, Precision Montage™, Precision Montage™ MRI, Spectra WaveWriter, WaveWri
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS366
Date Received08/31/2023
Decision Date09/27/2023
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  
Alternate packaging supplier for an Inner Tray packaging component used to package Spinal Cord Stimulator and Deep Brain Stimulator Lead Products (Extensions, Splitters, Adapters, and Connectors) at the Boston Scientific Dorado Puerto Rico manufacturing site.
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