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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Coaptite


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General
Application Number P040047 / PAS001
Current Plan Approved 09/29/2008
Study Name OSB Lead-Coaptite
General Study Protocol Parameters
Study Design Prospective Cohort Study
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 the long term safety of Coaptite.
Study Population Description The study population is as per device indication. This device is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females.
Sample Size 450 women at 20 sites
Data Collection Primary objective is to evaluate the long term safety of Coaptite. This will be accomplished by performing 4-day voiding diaries at baseline and all follow up visits, recording time to additional coaptite treatment, recording of all Coaptite injections received, and correlating the number of re-treatments with adverse event rates
Follow-up Visits and Length of Follow-up There will be approximately 8 visits over a 3 years period (7 visits if there is only one treatment). The length of follow up is 3 years.
Final Study Results
Interim Safety Information 10% of patients have developed urge incontinence, which may be advisable to monitor.


OSB Lead-Coaptite Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's 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 09/30/2014 On Time
Final Report 11/30/2016   Overdue


Contact Us

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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