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®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System
• Generic Name: Stimulator, electrical, implanted, for parkinsonian symptoms
• Applicant: MEDTRONIC Inc.; 7000 CENTRAL AVENUE NE; MINNEAPOLIS, MN 55432-3576
• PMA Number: P960009
• Supplement Number: S478
• Date Received: 04/17/2024
• Decision Date: 02/20/2025
• Product Code: NHL
• Docket Number: 25M-0480
• Notice Date: 03/03/2025
• Advisory Committee: Neurology
• Clinical Trials: NCT04620551
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for a new optional programming feature called adaptive deep brain stimulation (aDBS). This device is indicated for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years’ duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2