ACC 3625 SCREENER BEI REDESIGN US MKT
NA - 3625
Device Description
An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: 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: EZW
Device Name: Stimulator, Electrical, Implantable, For Incontinence
Device Class: 3
Physical State: N/A
Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Submission Type ID: 2
Review Panel: GU
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: 876.5270
Third Party Flag: N
Medical Specialty: GU
Code: GZF
Device Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 882.5870
Third Party Flag: N
Medical Specialty: NE
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
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: 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: 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: 00613994752178
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