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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.
 
DeviceMedtronic Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS397
Date Received02/23/2021
Decision Date05/07/2021
Product Code MHY 
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 software changes to the Medtronic Model A620 Patient Programmer Application (PPA)which consist of 1) fixing a defect that prevents the software from communicating with certain Model B35200 INSs that have Tel-M IDs containing particular values, 2) updating the impedance test that is used to support the MRI eligibility feature of the A620 PPA, and 3) other minor changes and bug fixes.
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