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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long Term PAS


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General
Study Status Terminated
Application Number /
Requirement Number
H080002 / PAS001
Date Original Protocol Accepted 01/25/2010
Date Current Protocol Accepted 09/24/2013
Study Name Long Term PAS
Device Name MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
Clinical Trial Number(s) NCT00740870 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


Long Term PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/26/2010 07/19/2010 On Time
1 year report 01/25/2011 01/26/2011 Overdue/Received
18 month report 07/26/2011 07/26/2011 On Time
2 year report 01/25/2012 01/25/2012 On Time
30 month report 07/25/2012 07/25/2012 On Time
request to move report dates 08/10/2012 08/10/2012 On Time
3 year report 07/26/2013 07/26/2013 On Time
4 year report 07/26/2014 07/24/2014 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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