HDE supplement
H070005 S026: AmplatzerTM P.I. Muscular VSD Occluder
FDA HDE supplement · 30-day notice · ABBOTT MEDICAL
Key facts
| Original HDE | H070005 |
|---|---|
| Supplement number | S026 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | AmplatzerTM P.I. Muscular VSD Occluder |
| Generic name | Transcatheter septal occluder |
| Applicant | ABBOTT MEDICAL |
| Product code | MLV |
| Received date | Apr 29, 2026 |
| Decision date | May 29, 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: