In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The sponsor has created a registry-based study that will include all patients who have received
an AUS 800 or AUS 800 with IZ at a US-based site subsequent to October 13, 2006. It is a passive surveillance system where information is voluntarily submitted to AMS by the implanting physician and is tied to credit for new devices under warranty.
The purpose of the registry is to evaluate the long-term performance of the AUS 800 compared to the AUS 800 with IZ by evaluating infection, mechanical component and system failures and surgical revision. The study hypothesis is that there is equal survival time (based on device replacement due to infection or mechanical failure) for IZ impregnated versus unimpregnated devices.The objective of this post-approval registry is to evaluate the long term performance of the AMS 800 against the long term performance of the AMS 800 with InhibiZone as it relates to rate of infection, mechanical component or system failures and surgical revision rates.
Study Population Description
Study population is as per device indication. This device is used to treat urinary incontinence
due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
Sample Size
All comers registry
Data Collection
Primary endpoint is device replacement surgery
Followup Visits and Length of Followup
There are no follow up visits in this study; the entire study will include 5
