FDA product code PRL: Iliac Covered Stent, Arterial
PRL is the FDA product code for iliac covered stent, arterial. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PRL reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 6 recalls for PRL devices, 4 initiated in the last five years.
Definition
For the treatment of de novo or restenotic lesions found in iliac arteries
Classification
| Field | Value |
|---|---|
| Device name | Iliac Covered Stent, Arterial |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PRL devices
6 product recalls in 5 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2024-09-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code PRL?
PRL is the FDA product code for iliac covered stent, arterial. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PRL?
Class III. Typical premarket route: PMA.
Have PRL devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code PRL
- Run a recall and safety report across every PRL manufacturer
- Watch product code PRL 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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