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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.
 
DeviceSJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS037
Date Received02/13/2018
Decision Date07/19/2018
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for:1) P140009/S037: MR Conditional labeling, Firmware version 1.3, and Clinician Programmer and Patient Controller Apps version 3.7 (DBS MRI mode, DBS shared frequency mode, DBS Multistim Programming, DBS Monopolar Survey Mode, and minor software changes); and2) P010032/S141 and P150004/S20: Firmware version 1.3 and Clinician Programmer and Patient Controller Apps version 3.7 (minor software changes).
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