# P130013: Watchman Left Atrial Appendage (Laa) Closure Technology

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Mar 13, 2015 after 668 days
- Product code: NGV (System, Appendage Closure, Left Atrial)
- 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
- Aug 25, 2015 · Class II · Z-2765-2015: Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the D
- Aug 25, 2015 · Class II · Z-2766-2015: Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the D

Source page: https://510kreport.com/device/P130013
Methodology: https://510kreport.com/methodology