# P020047: Multi-Link Vision/Mini/8 Coronary Stent Systems

- Pathway: PMA
- Applicant: Abbott Vascular
- Decided: Jul 16, 2003 after 268 days
- Product code: MAF (Stent, Coronary)
- 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
- Jul 16, 2007 · Not classified · Z-1211-2007: The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
- Apr 1, 2003 · Not classified · Z-0775-03: Complaints that the stents are being dislodged from the delivery system.

Source page: https://510kreport.com/device/P020047
Methodology: https://510kreport.com/methodology