- Device
- Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S531
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-05-20
- Decision code
- APPR
- Date received
- 2026-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a revision to the stim engine integrated circuit (SEIC) for the impacted implantable neurostimulator models that increases robustness to low-energy cardioversion/defibrillation exposures