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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.
 
DeviceInfinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS063
Date Received07/27/2020
Decision Date08/18/2020
Product Codes MHY NHL PJS 
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 a minor design change to remove a microelectromechanical systems (MEMS) sensor, which is an accelerometer component on the IPG’s printed circuit board. This MEMS sensor was intended to detect and collect data on patient activity levels for research and development purposes only; it is not related to product performance.
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