PMA P960009S521
- Device
- Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S521
- Product code
- MHY
- Decision date
- 2025-11-13
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- approval for new materials for components used in the Model 8880T2 Clinician Telemetry Module
Current openFDA PMA Record#
- Device
- Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S521
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2025-11-13
- Decision code
- APPR
- Date received
- 2025-09-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for new materials for components used in the Model 8880T2 Clinician Telemetry Module