HDE supplement
H070004 S045: CentriMag™ Right Ventricular Assist System
FDA HDE supplement · normal 75 day track · Abbott
Key facts
| Original HDE | H070004 |
|---|---|
| Supplement number | S045 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | CentriMag™ Right Ventricular Assist System |
| Generic name | Right ventricular bypass (assist) device |
| Applicant | Abbott |
| Product code | OJE |
| Received date | Feb 2, 2026 |
| Decision date | Apr 17, 2026 |
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: