- Device
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (B31050, B31040, B31010, B31000, B32000, B31061, B31
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S539
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-08-21
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of an ethylene oxide sterilization process by a contract manufacturer for certain products