FDA product code MAE: Occluder, Patent Ductus, Arteriosus
MAE is the FDA product code for occluder, patent ductus, arteriosus. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MAE reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 5 recalls for MAE devices.
Classification
| Field | Value |
|---|---|
| Device name | Occluder, Patent Ductus, Arteriosus |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MAE devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-09-06.
Frequently asked questions
What is FDA product code MAE?
MAE is the FDA product code for occluder, patent ductus, arteriosus. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MAE?
Class III. Typical premarket route: PMA.
Have MAE devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2005-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MAE
- Run a recall and safety report across every MAE manufacturer
- Watch product code MAE 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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