510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OLMHumanitarian device exemption

Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)

Unknown
FDA source (opens on fda.gov)

OLM is the FDA product code for Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd). FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OLM
Device name
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
FDA 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).
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code