HDE supplement
H070004 S018: CentriMag Right Ventricular Assist System (RVAS)
FDA HDE supplement · special (immediate track) · Abbott
Key facts
| Original HDE | H070004 |
|---|---|
| Supplement number | S018 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | CentriMag Right Ventricular Assist System (RVAS) |
| Generic name | Right ventricular bypass (assist) device |
| Applicant | Abbott |
| Product code | OJE |
| Received date | Aug 28, 2018 |
| Decision date | Sep 12, 2018 |
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: