FDA product code PNF: Aortic Stent
PNF is the FDA product code for aortic stent. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PNF reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Coarctation of the Aorta
Classification
| Field | Value |
|---|---|
| Device name | Aortic Stent |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PNF devices
openFDA lists no recalls for product code PNF.
Frequently asked questions
What is FDA product code PNF?
PNF is the FDA product code for aortic stent. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PNF?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PNF
- Run a recall and safety report across every PNF manufacturer
- Watch product code PNF 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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