FDA product code MTE: System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
MTE is the FDA product code for system, pacing, temporary, acute, internal atrial defibrillation. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MTE reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for MTE devices
openFDA lists no recalls for product code MTE.
Frequently asked questions
What is FDA product code MTE?
MTE is the FDA product code for system, pacing, temporary, acute, internal atrial defibrillation. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MTE?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTE
- Run a recall and safety report across every MTE manufacturer
- Watch product code MTE 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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