HDE supplement
H020007 S414: DBS Model B35300; DBS Neurostimulator Implantable Model B35200; DBS Neurostimulators Implantable Activa Family Models 3
FDA HDE supplement · 30-day notice · Medtronic Neuromodulation
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S414 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | DBS Model B35300; DBS Neurostimulator Implantable Model B35200; DBS Neurostimulators Implantable Activa Family Models 3 |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | Medtronic Neuromodulation |
| Product code | MRU |
| Received date | Jan 13, 2026 |
| Decision date | Feb 12, 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: