# P200045: RelayPro Thoracic Stent-Graft System

- Pathway: PMA
- Applicant: Bolton Medical, Inc.
- Decided: Aug 5, 2021 after 258 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 2 (1 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.
1 of 1 device in its family (counting itself) has 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
- Apr 22, 2026 · Class I · Z-2160-2026: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- Feb 22, 2024 · Class II · Z-1383-2024: The stent-graft inside the delivery system was the incorrect size.

Source page: https://510kreport.com/device/P200045
Methodology: https://510kreport.com/methodology