# P870078: Hancock Porcine Bioprosthesis

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Sep 28, 1989 after 660 days
- Product code: DYE (Replacement Heart-Valve)
- Device class: 3
- Regulation: 21 CFR 870.3925
- 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
- Aug 15, 2014 · Class II · Z-2623-2014: Medtronic has decided to discontinue production and distribution of this low-volume product.

Source page: https://510kreport.com/device/P870078
Methodology: https://510kreport.com/methodology