FDA product code OLM: Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
OLM is the FDA product code for deep brain stimulator for obsessive compulsive disorder (ocd). It is a HDE device, reviewed by the Neurology panel. Devices under OLM reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs).
Classification
| Field | Value |
|---|---|
| Device name | Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for OLM devices
openFDA lists no recalls for product code OLM.
Frequently asked questions
What is FDA product code OLM?
OLM is the FDA product code for deep brain stimulator for obsessive compulsive disorder (ocd). It is a HDE device, reviewed by the Neurology panel.
What device class is OLM?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OLM
- Run a recall and safety report across every OLM manufacturer
- Watch product code OLM 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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