HDE
H050003: MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY
FDA Humanitarian Device Exemption · MEDTRONIC INC.,NEUROLOGICAL DIVISION
Key facts
| HDE number | H050003 |
|---|---|
| Trade name | MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY |
| Generic name | Deep brain stimulator for obsessive compulsive disorder (ocd) |
| Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| Owner/operator | Medtronic, Inc. |
| Product code | OLM |
| Approval date | Feb 10, 2009 |
| Docket number | 09M-0090 |
| Establishment registration | 3015544746 |
| FEI number | 3015544746 |
At a glance
- 100–999 Supplements
- Sep 24, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 100–999 UDI device identifiers (GUDID)
- 100–999 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: