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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-Extended Use Stability Study

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Application Number P080012 / PAS002
Current Plan Approved 05/04/2012
Study Name OSB Lead-Extended Use Stability Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a non-clinical study.
Study Population Description Not applicable. This is a bench/lab study.
Sample Size 16 pumps will be used in this study.
Data Collection The stability of the Infumorph solution in the Prometra infusion pumps will be assessed for a period of 90 days and that stability will be assessed for multiple refills (on a 90 day cycle) for a period of 10 years. The pump flow rate will also be assessed during this study as sample volumes removed will be measured versus the expected quantities.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.

OSB Lead-Extended Use Stability Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/07/2012 07/24/2012 On Time
one year report 02/06/2013 02/06/2013 On Time
18 month report 08/07/2013 08/05/2013 On Time
two year report 02/06/2014 02/06/2014 On Time
30 month report 08/06/2014 08/04/2014 On Time
three year report 02/06/2015 02/06/2015 On Time
four year report 02/06/2016 02/05/2016 On Time
five year report 02/05/2017    
six year report 02/05/2018    
eight year report 02/05/2020    
nine year report 02/04/2021    
Final report 06/04/2021    
ten year report 02/04/2022    

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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