PMA P960009S524

Device: Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S524
Product code: MHY
Decision date: 2025-12-08
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval for updates to the Model A610 Deep Brain Stimulation Clinician Programmer Application version 5.0, which updates background loading of event logs, user interface revisions, and bug fix revisions.

Current openFDA PMA Record#

Device: Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S524
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2025-12-08
Decision code: APPR
Date received: 2025-09-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for updates to the Model A610 Deep Brain Stimulation Clinician Programmer Application version 5.0, which updates background loading of event logs, user interface revisions, and bug fix revisions.