HDE supplement
H020007 S421: Activa™ Dystonia Therapy System; Percept™ PC BrainSense™ (3387S, 3389S, B31010)
FDA HDE supplement · 30-day notice · Medtronic Neuromodulation
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S421 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Activa™ Dystonia Therapy System; Percept™ PC BrainSense™ (3387S, 3389S, B31010) |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | Medtronic Neuromodulation |
| Product code | MRU |
| Received date | Apr 24, 2026 |
| Decision date | May 22, 2026 |
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: