HDE supplement
H020007 S411: Activa™ Dystonia Therapy System, Percept PC BrainSense™
FDA HDE supplement · normal 75 day track · Medtronic Neuromodulation
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S411 |
| Supplement type | normal 75 day track |
| Reason for the supplement | location change - manufacturer/sterilizer/packager/supplier |
| Trade name | Activa™ Dystonia Therapy System, Percept PC BrainSense™ |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | Medtronic Neuromodulation |
| Product code | MRU |
| Received date | Oct 16, 2025 |
| Decision date | Nov 26, 2025 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: