FDA product code LOZ: Artificial Heart
LOZ is the FDA product code for artificial heart. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LOZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 5 recalls for LOZ devices, 2 initiated in the last five years.
Definition
P030011
Classification
| Field | Value |
|---|---|
| Device name | Artificial Heart |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LOZ devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2023-08-01.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code LOZ?
LOZ is the FDA product code for artificial heart. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LOZ?
Class III. Typical premarket route: PMA.
Have LOZ devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2023-08-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LOZ
- Run a recall and safety report across every LOZ manufacturer
- Watch product code LOZ 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.
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