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

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OSB Lead-Continued F/u of the Premarket ADO II PAS

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Application Number P020024 S037/ PAS001
Current Plan Approved 11/08/2013
Study Name OSB Lead-Continued F/u of the Premarket ADO II PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description To examine the long term safety and effectiveness of the ADO II through continued follow-up of the 178 subjects from the ADO II IDE study in whom device placement has occurred.

Study Population Description Subjects implanted with an ADO II device. No comparison group.
Sample Size A total of 178 subjects were enrolled in the ADO II IDE study and were implanted with the device.

Data Collection The primary ADO II PAS safety objective is to evaluate the rate of device serious adverse events (SAE) reported from the procedure through 5 years post-procedure.

Follow-up Visits and Length of Follow-up 5 years post-procedure - annual visits

OSB Lead-Continued F/u of the Premarket ADO II PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 08/18/2014 08/13/2014 On Time
two year report 08/18/2015 07/30/2015 On Time
Final Report 12/30/2016 02/17/2017 Overdue/Received

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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