LEAD 3391S
DBS - 3391S-40
Device Description
An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.
Environmental Conditions
- 57.00
- -34.00
- 135.00
- -30.00
Device Sizes
- Length: 40.0 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OLM
Device Name: Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
Device Class: f
Physical State: Electrodes, extension and IPG
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).
Submission Type ID: 6
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Deep brain stimulation
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Anterior limb of the internal capsule in the brain
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00643169516786
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A