HDE supplement
H000001 S027: GRAFTMASTER Coronary Stent Graft System
FDA HDE supplement · 30-day notice · ABBOTT VASCULAR DEVICES
Key facts
| Original HDE | H000001 |
|---|---|
| Supplement number | S027 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | GRAFTMASTER Coronary Stent Graft System |
| Generic name | Coronary covered stent |
| Applicant | ABBOTT VASCULAR DEVICES |
| Product code | NIV |
| Received date | Sep 9, 2024 |
| Decision date | Sep 20, 2024 |
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: