HDE
H020007: MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM
FDA Humanitarian Device Exemption · MEDTRONIC NEUROMODULATION
Key facts
| HDE number | H020007 |
|---|---|
| Trade name | MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | MEDTRONIC NEUROMODULATION |
| Owner/operator | Medtronic, Inc. |
| Product code | MRU |
| Approval date | Apr 15, 2003 |
| Docket number | 03M-0157 |
| Establishment registration | 2182207 |
| FEI number | 2182207 |
At a glance
- 100–999 Supplements
- Aug 8, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 100–999 UDI device identifiers (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 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: