HDE
H230007: AMDS Hybrid Prosthesis
FDA Humanitarian Device Exemption · Artivion, Inc.
Key facts
| HDE number | H230007 |
|---|---|
| Trade name | AMDS Hybrid Prosthesis |
| Generic name | Hybrid stent graft, thoracic aortic lesion treatment |
| Applicant | Artivion, Inc. |
| Owner/operator | Artivion, Inc. |
| Product code | QSK |
| Approval date | Dec 4, 2024 |
| Establishment registration | 1063481 |
| FEI number | 3001451326 |
At a glance
- None Supplements
- Dec 4, 2024 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- None 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: