FDA product code MAF: Stent, Coronary
MAF is the FDA product code for stent, coronary. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MAF reach the market by PMA; FDA lists no cleared 510(k)s for it. 24 PMA applications cite this product code. FDA has posted 22 recalls for MAF devices.
Definition
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Coronary |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MAF devices
22 product recalls in 16 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-10-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code MAF?
MAF is the FDA product code for stent, coronary. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MAF?
Class III. Typical premarket route: PMA.
Have MAF devices been recalled?
Yes: 22 product recalls across 16 recall events; the most recent began 2019-10-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MAF
- Run a recall and safety report across every MAF manufacturer
- Watch product code MAF 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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