HDE supplement
H020003 S018: CONTEGRA PULMONARY VALVED CONDUIT
FDA HDE supplement · 30-day notice · Medtronic, Inc.
Key facts
| Original HDE | H020003 |
|---|---|
| Supplement number | S018 |
| Supplement type | 30-day notice |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | CONTEGRA PULMONARY VALVED CONDUIT |
| Generic name | Replacement heart-valve |
| Applicant | Medtronic, Inc. |
| Product code | DYE |
| Received date | Apr 2, 2013 |
| Decision date | Sep 24, 2013 |
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: