GASTROENTEROLOGY AND UROLOGY DEVICES PANEL
of the Medical Devices Advisory Committee

August 17, 2001

Acticon™ Neosphincter P010020

Briefing Information

American Medical Systems

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Public Information Release Letter   pdf

Draft Summary of Safety and Effectiveness  pdf   htm

Patient Information   pdf

Guide for Women   pdf

Guide for Men   pdf

Manual   pdf