# P990046: Ats Open Pivot Bileaflet Heart Valve

- Pathway: PMA
- Applicant: Medtronic Ats Medical, Inc.
- Decided: Oct 13, 2000 after 442 days
- Product code: LWQ (Heart-Valve, Mechanical)
- 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
- Feb 11, 2020 · Class II · Z-1533-2020: Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
- Feb 18, 2004 · Not classified · Z-0634-04: Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.

Source page: https://510kreport.com/device/P990046
Methodology: https://510kreport.com/methodology