# P190023: Portico Transcatheter Aortic Valve Implantation System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Sep 17, 2021 after 739 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: 5 (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
- Oct 17, 2024 · Class II · Z-0491-2025: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact
- Oct 17, 2024 · Class II · Z-0494-2025: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact
- Oct 17, 2024 · Class II · Z-0495-2025: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact
- Oct 17, 2024 · Class II · Z-0492-2025: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact
- Oct 17, 2024 · Class II · Z-0493-2025: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact

Source page: https://510kreport.com/device/P190023
Methodology: https://510kreport.com/methodology