HDE supplement
H080002 S030: ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
FDA HDE supplement · normal 75 day track · Medtronic, Inc
Key facts
| Original HDE | H080002 |
|---|---|
| Supplement number | S030 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM |
| Generic name | Pulmonic valved conduit |
| Applicant | Medtronic, Inc |
| Product code | MWH |
| Received date | Aug 21, 2014 |
| Decision date | Sep 20, 2014 |
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: