# P250024: Trilogy Transcatheter Heart Valve System

- Pathway: PMA
- Applicant: JenaValve Technology, Inc.
- Decided: Mar 17, 2026 after 260 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: 3 (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
- Jul 31, 2026 · Class II · Z-0136-2027: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Jul 31, 2026 · Class II · Z-0134-2027: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- Jul 31, 2026 · Class II · Z-0135-2027: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Source page: https://510kreport.com/device/P250024
Methodology: https://510kreport.com/methodology