Data / Medical devices / System, Appendage Closure, Left Atrial
System, Appendage Closure, Left Atrial (NGV): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make System, Appendage Closure, Left Atrial (product code NGV, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- NGV
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Costa Rica | 1 |
| Ireland | 1 |
Makers of System, Appendage Closure, Left Atrial
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Plymouth, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Saint Paul, MN, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical Costa Rica Limitada (Structural Heart) | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.