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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-Nit-Occlud PDA PAS

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Application Number P120009 / PAS001
Current Plan Approved 08/01/2014
Study Name OSB Lead-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 The study is a controlled, prospective, single-arm, multi-center trial with newly enrolled patients.
Study Population Description Patients who have successful Nit-Occlud PDA device implantation
Sample Size 215 patients from up to 20 sites to achieve a sample size of 150 subjects

available at 60 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

OSB Lead-Nit-Occlud PDA PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/14/2014 02/21/2014 Overdue/Received
one year report 08/16/2014 08/18/2014 Overdue/Received
18 month report 02/14/2015 02/18/2015 Overdue/Received
two 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
three year report 08/15/2016 08/15/2016 On Time
four year report 08/15/2017    
five year report 08/15/2018    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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