Device typeImplantable incontinence-control electrical stimulation system pulse generator: 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.
FDA categoryStimulator, tibial, electrical, implantable, for urinary incontinence
Device ID00763000936433
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional