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Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)

OLM · f · Unknown

Classification

FDA Product Code
OLM
Device class
f
Regulation
Review panel
NE
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

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).

Market data

Cleared 510(k) submissions
0
Registered establishments
8

Source

Authoritative
FDA Device Classification database
Machine
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