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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.
 
DeviceBRIO NEUROSTIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS115
Date Received02/14/2025
Decision Date03/13/2025
Product Codes MHY NHL PJS 
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  
a supplier manufacturing site relocation from Heraeus Medevio Centerville, White Bear Lake (HMCW) to Heraeus Medevio Puerto Rico (HMPR) for the Stylet component of the impacted products and to purchase wire material which is already straightened, cut and coated from their current supplier, Fort Wayne Metals (FWM)
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