# P200049: Amplatzer™ Amulet™ Left Atrial Appendage Occluder

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Aug 14, 2021 after 226 days
- Product code: NGV (System, Appendage Closure, Left Atrial)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 10, 2026 · Class II · Z-0191-2027: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).

Source page: https://510kreport.com/device/P200049
Methodology: https://510kreport.com/methodology