ENS 37022 EXTERNAL STIM DBS EMANUAL EN

ENS 37022 EXTERNAL STIM DBS EMANUAL EN
N/A - 37022

An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).

No Data Available

No Data Available

Device Sterile: False

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

Code: PJS

Device Name: Stimulator, Electrical, Implanted, For Essential Tremor

Device Class: 3

Physical State: System components include implantable pulse generator, leads, extensions, patient programmer, and charger

Definition: Deep Brain Stimulation for the treatment of essential tremor

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Implantable pulse generator will produce electrical pulses which will stimulate deep brain structures through electrodes on leads.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Deep Brain Structures

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: MBX

Device Name: Stimulator, Thalamic, Epilepsy, Implanted

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 3

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: NHL

Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

Device Class: 3

Physical State: N/A

Definition: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: MHY

Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: MRU

Device Name: Implanted Subcortical Electrical Stimulator (Motor Disorders)

Device Class: f

Physical State: N/A

Definition: N/A

Submission Type ID: 6

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: MFR

Device Name: Stimulator, Brain, Implanted, For Behavior Modification

Device Class: f

Physical State: N/A

Definition: N/A

Submission Type ID: 6

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: LGW

Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000404413

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