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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 NumberS048
Date Received07/01/2019
Decision Date07/29/2019
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  
Move FMI manufacturing operations from its current site at Elk Grove Village, Illinois, USA to a facility in Lincolnshire, Illinois, USA. FMI is the currently approved supplier for molded silicone parts that go into the finished assembly and packaging of implantable pulse generators (IPGs), leads, lead extensions, lead adapters, and lead accessories.
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