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AMS 800 Artificial Urinary Sphincter
Pressure Regulating Balloon
Details
Device typeUrethral sphincter prosthesis, non-powered: An implantable assembly of non-electric devices intended to support or replace a natural urethral sphincter for the management of incontinence. It is a hydraulically-operated system typically consisting of a cuff to surround the urethra, a reservoir for the hydraulic liquid (e.g., saline with/without radiopacifier), and a manually driven pump.
FDA categoryDevice, Incontinence, Mechanical/Hydraulic
Device ID00878953000619
Catalog number72400023
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Size51-60 cmH2O Pressure