# P120003: iCast Covered Stent System

- Pathway: PMA
- Applicant: Atrium Medical Corp.
- Decided: Mar 22, 2023 after 4,031 days
- Product code: PRL (Iliac Covered Stent, Arterial)
- 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
- Sep 21, 2023 · Class II · Z-0291-2024: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.

Source page: https://510kreport.com/device/P120003
Methodology: https://510kreport.com/methodology