ACCY 3550
N/A - 3550-05
Device Description
A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
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: GZB
Device Name: Stimulator, Spinal-Cord, 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: 882.5880
Third Party Flag: N
Medical Specialty: NE
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: 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: QON
Device Name: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Device Class: 3
Physical State: Receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body
Definition: Treatment of chronic fecal incontinence
Submission Type ID: 2
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Electrical stimulation of the sacral nerve
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Sacral nerve, bladder, urinary and anal sphincters, pelvic floor, and rectosigmoid colon
Regulation Number: 876.5270
Third Party Flag: N
Medical Specialty: GU
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: 00643169953574
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
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