HDE
H000001: JOMED JOSTENT CORONARY STENT GRAFT
FDA Humanitarian Device Exemption · ABBOTT VASCULAR DEVICES
Key facts
| HDE number | H000001 |
|---|---|
| Trade name | JOMED JOSTENT CORONARY STENT GRAFT |
| Generic name | Coronary covered stent |
| Applicant | ABBOTT VASCULAR DEVICES |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIV |
| Approval date | Jan 10, 2001 |
| Docket number | 01M-0062 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Feb 26, 2025 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1,000+ 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: