# P110021: Edwards Sapien Transcatheter Heart Valve and Accessories

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 19, 2012 after 536 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- 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
- Mar 26, 2013 · Class II · Z-1134-2013: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
- Mar 26, 2013 · Class II · Z-1135-2013: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.

Source page: https://510kreport.com/device/P110021
Methodology: https://510kreport.com/methodology