FDA product code MMY: Lipoprotein, Low Density, Removal
MMY is the FDA product code for lipoprotein, low density, removal. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MMY reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 2 recalls for MMY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lipoprotein, Low Density, Removal |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MMY devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-02-17.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MMY?
MMY is the FDA product code for lipoprotein, low density, removal. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MMY?
Class III. Typical premarket route: PMA.
Have MMY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-02-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MMY
- Run a recall and safety report across every MMY manufacturer
- Watch product code MMY 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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