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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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Extended Use Stability Study

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Study Status Progress Adequate
Application Number P080012 / PAS002
Date Current Protocol Accepted 05/04/2012
Study Name 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

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 02/09/2017 Overdue/Received
six year report 02/05/2018 02/16/2018 Overdue/Received
seven year report 02/05/2019   Overdue
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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