# P020009: Express/Express 2 MR & Otw Coronary Stent Systems

- Pathway: PMA
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Sep 11, 2002 after 180 days
- Product code: MAF (Stent, Coronary)
- Device class: 3
- Recalls of this device: 3 (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, 2004 · Not classified · Z-1121-04: Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
- Jul 16, 2003 · Not classified · Z-1123-03: There is an Increased potential for broken struts of the stents.
- Mar 20, 2003 · Not classified · Z-0711-03: The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.

Source page: https://510kreport.com/device/P020009
Methodology: https://510kreport.com/methodology