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
- 2026-08-14
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.
Current openFDA PMA Record#
- Device
- Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S541
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-08-14
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.