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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.
 
DeviceGENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS011
Date Received01/27/2016
Decision Date02/26/2016
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the sampling interval for bioburden and bacterial endotoxin testing of the two process water systems at the Plano, Texas manufacturing facility.
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