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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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Nit-Occlud PDA PAS

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Study Status Progress Adequate
Application Number P120009 / PAS001
Date Current Protocol Accepted 12/16/2016
Study Name Nit-Occlud PDA PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description This is a controlled, prospective, single-arm, multi-center (up to 20 sites) study. Enrolled subjects will be followed at 2, 12, and
24 months (2 years) post implant.
Study Population Description Patients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter < 4 mm.
Sample Size A total of 180 subjects will be enrolled to ensure 150 subjects treated with the device will be available at 24 months post-procedure.
Data Collection The primary safety endpoint is the serious device and/or procedure related
adverse event rate at 60 months post-procedure.

The primary effectiveness endpoint is the rate of complete closure of the ductus arteriosus as assessed by absence of residual flow at 5 years follow-up by by transthoracic echocardiogram with 2-D color of color flow mapping and pulse wave Doppler (ECHO).
Follow-up Visits and Length of Follow-up 5 years
Clinical assessments at 2, 12, 24, 36, 48, and 60 months
Echocardiography at 2, 12, 36, and 60 months

Nit-Occlud PDA PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 02/14/2014 02/21/2014 Overdue/Received
1 year report 08/16/2014 08/18/2014 Overdue/Received
18 month report 02/14/2015 02/18/2015 Overdue/Received
2 year report 08/16/2015 08/25/2015 Overdue/Received
30 month report 02/15/2016 02/16/2016 Overdue/Received
duplicate 2 year report 04/12/2016 04/12/2016 On Time
3 year report 08/15/2016 08/15/2016 On Time
4 year report 08/15/2017 08/15/2017 On Time
5 year report 08/15/2018 08/10/2018 On Time
6 year report 08/15/2019 08/14/2019 On Time
7 year report 08/15/2020 08/14/2020 On Time
8 year report 08/15/2021 08/12/2021 On Time
final report 10/15/2022    

Contact Us

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

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