HDE supplement
H070005 S012: Amplatzer Post-infarct Muscular VSD Occluder
FDA HDE supplement · normal 75 day track · Abbott Medical
Key facts
| Original HDE | H070005 |
|---|---|
| Supplement number | S012 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol |
| Trade name | Amplatzer Post-infarct Muscular VSD Occluder |
| Generic name | Transcatheter septal occluder |
| Applicant | Abbott Medical |
| Product code | MLV |
| Received date | Nov 25, 2019 |
| Decision date | Jan 24, 2020 |
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: