Premarket Approval (PMA)

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.

• Device: Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
• Generic Name: Stimulator, electrical, implanted, for parkinsonian tremor
• Applicant: Medtronic, Inc.; 7000 Central Ave., NE; Minneapolis, MN 55432
• PMA Number: P960009
• Supplement Number: S451
• Date Received: 04/04/2023
• Decision Date: 05/04/2023
• Product Code: MHY
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of an automatic process monitoring station for batteries manufactured at Medtronic Energy and Component Center (MECC).