PMA P960009S522

Device: Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S522
Product code: MHY
Decision date: 2025-10-16
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: for update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).

Current openFDA PMA Record#

Device: Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S522
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).