- Device
- Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S520
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-02-11
- Decision code
- APPR
- Date received
- 2025-08-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a new solvent cleaner to be used in the Precision Machining & Manufacturing (PMM) processes