HDE supplement
H050003 S363: DBS Neurostimulator Implantable Model B35200; DBS Neurostimulators Implantable Activa Family Models 37601, 37602, 37603
FDA HDE supplement · 30-day notice · Medtronic Inc.,Neurological Division.
Key facts
| Original HDE | H050003 |
|---|---|
| Supplement number | S363 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | DBS Neurostimulator Implantable Model B35200; DBS Neurostimulators Implantable Activa Family Models 37601, 37602, 37603 |
| Generic name | Deep brain stimulator for obsessive compulsive disorder (ocd) |
| Applicant | Medtronic Inc.,Neurological Division. |
| Product code | OLM |
| 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: