FDA product code NGV: System, Appendage Closure, Left Atrial
NGV is the FDA product code for system, appendage closure, left atrial. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NGV reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for NGV devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Appendage Closure, Left Atrial |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NGV devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NGV?
NGV is the FDA product code for system, appendage closure, left atrial. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NGV?
Class III. Typical premarket route: PMA.
Have NGV devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2018-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code NGV
- Run a recall and safety report across every NGV manufacturer
- Watch product code NGV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times