# P990020: Aneurx Stent Graft System

- Pathway: PMA
- Applicant: Medtronic Vascular
- Decided: Sep 28, 1999 after 169 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 2 (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
- Apr 29, 2008 · Not classified · Z-1918-2008: Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.
- Dec 10, 2007 · Not classified · Z-0689-2008: Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.

Source page: https://510kreport.com/device/P990020
Methodology: https://510kreport.com/methodology