PMA P960009S416

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S416
Product code: MHY
Decision date: 2022-01-19
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Change in the ceramic material for multi-layer ceramic capacitors (MLCC) at Medtronics supplier. The components impacted are used within the hybrid electronic modules manufactured by Medtronics internal supplier.

Current openFDA PMA Record#

Device: Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S416
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the ceramic material for multi-layer ceramic capacitors (MLCC) at Medtronics supplier. The components impacted are used within the hybrid electronic modules manufactured by Medtronics internal supplier.