EXT B3400040 SENSIGHT NO MKR EMAN LJ53
SenSight™ - B3400040
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
No Data Available
Device Sizes
- Length: 40.0 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: 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: 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: 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 IdentifiersDevice Id: 00763000426453
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