HDE
H080002: MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
FDA Humanitarian Device Exemption · Medtronic, Inc
Key facts
| HDE number | H080002 |
|---|---|
| Trade name | MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Medtronic, Inc |
| Owner/operator | Medtronic, Inc. |
| Product code | NPV |
| Approval date | Jan 25, 2010 |
| Docket number | 10M0063 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Nov 6, 2014 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 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: