HDE supplement
H070004 S010: LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
FDA HDE supplement · normal 75 day track · Abbott
Key facts
| Original HDE | H070004 |
|---|---|
| Supplement number | S010 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol - osb |
| Trade name | LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
| Generic name | Right ventricular bypass (assist) device |
| Applicant | Abbott |
| Product code | OJE |
| Received date | Feb 15, 2012 |
| Decision date | Jul 9, 2012 |
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: