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 URINARY CONTROL SYSTEM
• Classification Name: device, incontinence, mechanical/hydraulic
• Generic Name: urinary prosthesis
• Regulation Number: 876.5280
• Applicant: AMERICAN MEDICAL SYSTEMS, INC.
• PMA Number: P000053
• Supplement Number: S021
• Date Received: 02/18/2009
• Decision Date: 03/19/2009
• Product Code: EZY [ Registered Establishments with EZY ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Implementation of a back-up in-process tester.