FDA product code MOM: System, Hemodynamic, Implantable
MOM is the FDA product code for system, hemodynamic, implantable. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MOM reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 13 recalls for MOM devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Hemodynamic, Implantable |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MOM devices
13 product recalls in 7 recall events; 12 initiated in the last five years and 12 still open. Most recent: 2025-02-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 8 |
| 2024 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MOM?
MOM is the FDA product code for system, hemodynamic, implantable. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MOM?
Class III. Typical premarket route: PMA.
Have MOM devices been recalled?
Yes: 13 product recalls across 7 recall events; the most recent began 2025-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MOM
- Run a recall and safety report across every MOM manufacturer
- Watch product code MOM 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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