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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 DBS Systems
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS077
Date Received05/23/2022
Decision Date08/19/2022
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for version 3.11 of the Clinician Programmer and Patient Controller applications which merge previously approved software features into a single version and include minor enhancements and administrative updates. In addition, approval for four new Proclaim SCS Implantable Pulse Generator (IPG) models (models 3670, 3671, 3672, and 3673).
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