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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 NumberS511
Date Received06/20/2025
Decision Date07/17/2025
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
reduced bacterial endotoxin testing frequency and sample size for the Connector Plug Accessory Kit (model B31060), the Bolero Interstim Revision Kit (model 3560031), the Tunneling Tools and Catheter Passers, the Torque Wrenches and Injex families manufactured at Juncos, Puerto Rico facility
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