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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.
 
DeviceMaster Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS419
Date Received01/26/2022
Decision Date04/06/2022
Product Code MHY 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the primary Information for Prescribers (IFP) clinician labeling, and update to the primary Patient Therapy Guide (PTG) to mitigate the potential for implantable neurostimulator (INS) malfunction during a cardioversion procedure.
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