HDE
H070005: THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER
FDA Humanitarian Device Exemption · Abbott Medical
Key facts
| HDE number | H070005 |
|---|---|
| Trade name | THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER |
| Generic name | Transcatheter septal occluder |
| Applicant | Abbott Medical |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MLV |
| Approval date | Jan 10, 2017 |
| Docket number | 17M-0180 |
| Notice date | Jan 12, 2017 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- May 29, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 10–99 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: