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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-Enhanced Surveillance Registry Study

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Study Status Completed
Application Number P110039 / PAS002
Date Current Protocol Accepted 03/15/2013
Study Name OSB Lead-Enhanced Surveillance Registry Study
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

OSB Lead-Enhanced Surveillance Registry Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/18/2013 06/18/2013 Overdue/Received
one year report 10/18/2013 10/28/2013 Overdue/Received
18 month report 04/18/2014 05/07/2014 Overdue/Received
two year report 10/18/2014 10/29/2014 Overdue/Received
three year report 10/18/2015 11/06/2015 Overdue/Received
four year report 10/18/2016 11/02/2016 Overdue/Received
final report 03/12/2017 04/06/2017 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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