EXTN 3095-25 KIT QD INLINE US 25CM BOWEL

EXTN 3095
INTERSTIM - 3095-25

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.

No Data Available

• Length: 25.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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

Device Id: 00613994571960

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