PMA P960009S478

Device: Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S478
Product code: NHL
Decision date: 2025-02-20
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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.

Current openFDA PMA Record#

Device: Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S478
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-02-20
Decision code: APPR
Date received: 2024-04-17
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
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.