PMA
P200049: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
FDA PMA · System, appendage closure, left atrial · ABBOTT MEDICAL
Key facts
| PMA number | P200049 |
|---|---|
| Trade name | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
| Generic name | System, appendage closure, left atrial |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NGV |
| Approval date | Aug 14, 2021 |
| Docket number | 21M-0911 |
| Notice date | Aug 21, 2021 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- Aug 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: