HDE supplement
H080002 S003: MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
FDA HDE supplement · 30-day notice · Medtronic, Inc
Key facts
| Original HDE | H080002 |
|---|---|
| Supplement number | S003 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Medtronic, Inc |
| Product code | NPV |
| Received date | Oct 20, 2010 |
| Decision date | Nov 19, 2010 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: