# P120006: Ovation Abdominal Stent Graft System

- Pathway: PMA
- Applicant: Endologix, LLC
- Decided: Oct 5, 2012 after 177 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 3 (2 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
- May 6, 2020 · Class I · Z-2263-2020: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. 
- Sep 20, 2014 · Class I · Z-0125-2015: TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector du
- Oct 19, 2012 · Class II · Z-0288-2013: Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock compon

Source page: https://510kreport.com/device/P120006
Methodology: https://510kreport.com/methodology