# P190015: TREO® Abdominal Stent-Graft System

- Pathway: PMA
- Applicant: Bolton Medical, Inc.
- Decided: May 4, 2020 after 336 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- 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
- May 3, 2023 · Class II · Z-1689-2023: Potential for the incorrect size stent-graft than the printed carton label.

Source page: https://510kreport.com/device/P190015
Methodology: https://510kreport.com/methodology