# P180029: LOTUS Edge Valve System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Apr 23, 2019 after 252 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: 6 (6 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
- Nov 17, 2020 · Class I · Z-0728-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Nov 17, 2020 · Class I · Z-0729-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Nov 17, 2020 · Class I · Z-0734-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Nov 17, 2020 · Class I · Z-0730-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Nov 17, 2020 · Class I · Z-0736-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Nov 17, 2020 · Class I · Z-0735-2021: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

Source page: https://510kreport.com/device/P180029
Methodology: https://510kreport.com/methodology