# P130021: Medtronic Corevalve System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jan 17, 2014 after 179 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: 4 (1 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.
1 of 1 device in its family (counting itself) has 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
- Oct 23, 2020 · Class II · Z-0559-2021: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
- Oct 23, 2020 · Class II · Z-0560-2021: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
- Oct 23, 2020 · Class II · Z-0561-2021: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
- Jul 15, 2015 · Class I · Z-2264-2015: Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

Source page: https://510kreport.com/device/P130021
Methodology: https://510kreport.com/methodology