LEAD 3391S-40 DBS HDE EMAN NO SCRNR CBL

LEAD 3391S
DBS - 3391S-40

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.

• Length: 40.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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