INS 97800 INTERSTIM X SSMRI AMER
InterStim™ X - 97800
Device Description
A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.
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: 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: 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
Device IdentifiersDevice Id: 00763000484668
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