# P020036: S.M.a.R.T. and S.M.a.R.T. Control Nitinol Stent System

- Pathway: PMA
- Applicant: Cordis US Corporation
- Decided: Aug 12, 2003 after 341 days
- Product code: NIO (Stent, Iliac)
- Device class: 3
- Recalls of this device: 4 (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
- Mar 4, 2025 · Class II · Z-1510-2025: product mix-up; Vascular stent labeled as one size but contains a different size.
- Nov 14, 2019 · Class II · Z-0728-2020: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- Jan 31, 2012 · Not classified · Z-1040-2012: Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches.
- Mar 10, 2008 · Not classified · Z-1556-2008: Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing 

Source page: https://510kreport.com/device/P020036
Methodology: https://510kreport.com/methodology