FDA product code LII: Monitor, Intracranial Pressure, Implanted
LII is the FDA product code for monitor, intracranial pressure, implanted. It is a Class III device, reviewed by the Neurology panel. Devices under LII reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Intracranial Pressure, Implanted |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LII devices
openFDA lists no recalls for product code LII.
Frequently asked questions
What is FDA product code LII?
LII is the FDA product code for monitor, intracranial pressure, implanted. It is a Class III device, reviewed by the Neurology panel.
What device class is LII?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LII
- Run a recall and safety report across every LII manufacturer
- Watch product code LII 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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