EXT B3400095 SENSIGHT NO MKR EMAN LJ53

EXT B3400095 SENSIGHT NO MKR EMAN LJ53
SenSight™ - B3400095

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.

No Data Available

• Length: 95.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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: 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

Device Id: 00763000426491

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