PMA · Approved
Recalled · Class II · 2015Watchman Left Atrial Appendage (Laa) Closure Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NGV System, Appendage Closure, Left Atrial
Approved on Mar 13, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 668-day review. It has been recalled 2 times.
- Decided
- Mar 13, 2015
- Review
- 668 days
- Class
- Class III
- Product code
- NGV
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P130013 has 84 supplements since 2015: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2015 | 3 |
| 2016 | 8 |
| 2017 | 5 |
| 2018 | 6 |
| 2019 | 10 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 8 |
| 2023 | 9 |
| 2024 | 8 |
| 2025 | 9 |
| 2026 | 7 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2015 | Class II | Z-2765-2015 | Use error | 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 Directions for Use (DFU) and gives… |
| Aug 25, 2015 | Class II | Z-2766-2015 | Use error | 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 Directions for Use (DFU) and gives… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NGV devicesNGV System, Appendage Closure, Left Atrial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NGV
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGV
Too few NGV 510(k)s in any year since 2007 to give a median.
Recalls per year · NGV
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGV
2,822in 2025
MAUDE reports naming product code NGV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 4 | — | 0 | 286 |
| 2016 | 8 | — | 0 | 621 |
| 2017 | 5 | — | 0 | 1,022 |
| 2018 | 6 | — | 0 | 1,019 |
| 2019 | 10 | — | 0 | 996 |
| 2020 | 5 | — | 0 | 935 |
| 2021 | 10 | — | 0 | 1,175 |
| 2022 | 9 | — | 0 | 1,493 |
| 2023 | 10 | — | 0 | 2,429 |
| 2024 | 11 | — | 0 | 2,698 |
| 2025 | 15 | — | 0 | 2,822 |
| 2026 | 12 | — | 1 | — |
https://510kreport.com/device/P130013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P130013: Watchman Left Atrial Appendage (Laa) Closure Technology.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P130013
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026