Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• Classification Name: device, incontinence, mechanical/hydraulic
• Generic Name: urinary prosthesis
• Regulation Number: 876.5280
• Applicant: AMERICAN MEDICAL SYSTEMS, INC.
• PMA Number: P000053
• Supplement Number: S019
• Date Received: 09/13/2008
• Decision Date: 10/09/2008
• Product Code: EZY [ Registered Establishments with EZY ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Additional sterilization unit at the facility.