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: ACTICON NEOSPHINCTER
• Classification Name: implanted fecal incontinence device
• Applicant: AMERICAN MEDICAL SYSTEMS, INC.
• PMA Number: P010020
• Supplement Number: S021
• Date Received: 09/28/2011
• Decision Date: 10/26/2011
• Product Code: MIP [ Registered Establishments with MIP ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Supplement Reason: process change: packaging
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in the packaging process for the devices.