HDE supplement
H000001 S014: GRAFT MASTER RX CORONARY STENT GRAFT SYSTM
FDA HDE supplement · normal 75 day track · ABBOTT VASCULAR DEVICES
Key facts
| Original HDE | H000001 |
|---|---|
| Supplement number | S014 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | GRAFT MASTER RX CORONARY STENT GRAFT SYSTM |
| Generic name | Coronary covered stent |
| Applicant | ABBOTT VASCULAR DEVICES |
| Product code | NIV |
| Received date | Dec 6, 2016 |
| Decision date | Feb 17, 2017 |
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: