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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 AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS422
Date Received02/24/2022
Decision Date03/25/2022
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
Approval Order Statement  
Approval of the following revisions to the protocol for the post-approval study (PAS), DBS for Epilepsy New Enrollment PAS: a) evaluate seizure worsening and changes in seizure frequency over time without formal hypothesis testing for safety; b) change the sample size for the primary effectiveness objective to approximately 72 evaluable subjects at 3 years (140 enrolled subjects to have 90 implanted subjects) from 112 evaluable subjects at 3 years (216 enrolled subjects to have 140 implanted subjects); c) change in baseline diary length from 84 days to 28 days; d) update to estimated study milestones; e) migration to a new Medtronic Clinical Investigation Plan (CIP) template; and f) general clerical edits (e.g., addition of lead Principal Investigator name and contact information, formatting, grammar/wording for consistency, improved readability, etc.).
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