f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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General
Study Status Hold
Application Number /
Requirement Number		 P080012 / PAS002
Date Original Protocol Accepted 05/04/2012
Date Current Protocol Accepted 05/04/2012
Study Name Extended Use Stability Study
Device Name PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives This is a non-clinical study.
Study Population Not applicable. This is a bench/lab study.
Sample Size 16 pumps will be used in this study.
Key Study Endpoints 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.


Extended Use Stability Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/07/2012 07/24/2012 On Time
1 year report 02/06/2013 02/06/2013 On Time
18 month report 08/07/2013 08/05/2013 On Time
2 year report 02/06/2014 02/06/2014 On Time
30 month report 08/06/2014 08/04/2014 On Time
3 year report 02/06/2015 02/06/2015 On Time
4 year report 02/06/2016 02/05/2016 On Time
5 year report 02/05/2017 02/09/2017 Overdue/Received
6 year report 02/05/2018 02/16/2018 Overdue/Received
7 year report 02/05/2019 02/12/2019 Overdue/Received
8 year report 02/05/2020 02/10/2020 Overdue/Received
9 year report 02/04/2021 02/08/2021 Overdue/Received
10 year report 02/04/2022 02/08/2022 Overdue/Received
11 year report 02/08/2023 02/07/2023 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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