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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • 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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P040047
Most Recent Protocol Version Approved 09/29/2008
Study Name Coaptite
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective cohort study of 450 women with stress urinary incontinence to study   show the rest ...
Study Population Description The study population is as per device indication. This device is indicated for soft tissue   show the rest ...
Sample Size 450 women at 20 sites
Data Collection Primary objective is to evaluate the long term safety of Coaptite. This will be accomplished   show the rest ...
Followup Visits and Length of Followup There will be approximately 8 visits over a 3 years period (7 visits if there   show the rest ...


Coaptite Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
18 month report 05/11/2007 11/16/2007 Overdue/Received
2 year report 11/10/2007 12/13/2007 Overdue/Received
FINAL REPORT 03/29/2009 04/01/2009 Overdue/Received
Status Report 04/06/2009 04/01/2009 On Time
Interim Report 10/01/2009 10/01/2009 On Time
Apr 2010 PAS report 03/30/2010 03/26/2010 On Time
September 2010 Report 09/30/2010 10/07/2010 Overdue/Received
September 2011 Report 09/30/2011 09/20/2011 On Time
September 2012 Report 09/30/2012 09/18/2012 On Time
September 2013 Report 09/30/2013 09/27/2013 On Time
September 2014 Report 09/30/2014    
September 2015 Final Report 09/30/2015    

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