PMA
P020024: AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
FDA PMA · OCCLUDER, PATENT DUCTUS, ARTERIOSUS · ABBOTT MEDICAL
Key facts
| PMA number | P020024 |
|---|---|
| Trade name | AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM |
| Generic name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MAE |
| Approval date | May 14, 2003 |
| Docket number | 06M-0075 |
| Notice date | Feb 16, 2006 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- May 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: