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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 IMPLANTABLE PULSE GENERATORS (IPGS)
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS012
Date Received02/02/2016
Decision Date03/03/2016
Product Codes MHY NHL 
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 manufacturing location for the SMT Level assemblies used in the manufacturing of the Implantable Pulse Generators (IPGs) and the external accessories for the Spinal Cord Stimulation and Deep Brain Stimulation systems.
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