HDE
H010004: NEUROLINK SYSTEM
FDA Humanitarian Device Exemption · ABBOTT VASCULAR-CARDIAC THERAPIES
Key facts
| HDE number | H010004 |
|---|---|
| Trade name | NEUROLINK SYSTEM |
| Generic name | Intracranial neurovascular stent |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NJE |
| Approval date | Aug 9, 2002 |
| Docket number | 02M-0361 |
| Establishment registration | 2939561 |
| FEI number | 3004635528 |
At a glance
- None Supplements
- Aug 9, 2002 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- 1–9 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: