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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.
 
DeviceActiva® 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 NumberS433
Date Received07/05/2022
Decision Date08/03/2022
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to 1) Change in Exclusion Criterion #4 to state Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit; and 2) Change in Implant Eligibility Criterion #4 to state, Change to: No suicide attempt or other self-harm behaviors within past year (assessed by C-SSRS at 3-month CMM Visit).
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