HDE
H020003: CONTEGRA PULMONARY VALVED CONDUIT
FDA Humanitarian Device Exemption · Medtronic, Inc.
Key facts
| HDE number | H020003 |
|---|---|
| Trade name | CONTEGRA PULMONARY VALVED CONDUIT |
| Generic name | Pulmonic valved conduit |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | MWH |
| Approval date | Nov 21, 2003 |
| Docket number | 03M-0536 |
| Establishment registration | 2025587 |
| FEI number | 2025587 |
At a glance
- 10–99 Supplements
- Jun 9, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 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: