# P140028: Innova Vascular Self-Expanding Stent with Delivery System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Jul 21, 2015 after 223 days
- Product code: NIP (Stent, Superficial Femoral Artery)
- 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
- Nov 6, 2017 · Class II · Z-0685-2018: Stent possibly unable to be fully released from the delivery system.
- Nov 6, 2017 · Class II · Z-0686-2018: Stent possibly unable to be fully released from the delivery system.

Source page: https://510kreport.com/device/P140028
Methodology: https://510kreport.com/methodology