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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 PATIENT PROGRAMMER
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS002
Date Received08/04/2015
Decision Date11/02/2015
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE RESIN MATERIAL (C1200HF) TO BE USED IN THE MANUFACTURE OF THE OUTER CASING OF THE GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTÉGÉ PROGRAMMER, PATIENT PROGRAMMER -MRI, AND BRIO PATIENT PROGRAMMER.
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