PMA P960009

Device: Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S446
Product code: MHY
Decision date: 2026-06-16
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.

Current openFDA PMA Record#

Device: Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S537
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-06-16
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.