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
- 2026-10-06
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)
Current openFDA PMA Record#
- Device
- Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S542
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-10-06
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)