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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Leachables Study


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General
Study Status Completed
Application Number /
Requirement Number		 P890055 S026/ PAS002
Date Original Protocol Accepted 12/17/2010
Date Current Protocol Accepted 03/15/2011
Study Name Leachables Study
Device Name CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
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 Objectives The non-clinical study includes extraction and leachables testing. There are no stated hypotheses.
Study Population Not applicable. This is a bench/lab study.
Sample Size Not applicable. This is a bench/lab study.
Key Study Endpoints In order to determine the endpoints extraction testing and leachable testing will be performed.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.
Interim or Final Data Summary
Actual Number of Patients Enrolled N/A Bench Study
Actual Number of Sites Enrolled N/A Bench Study
Patient Follow-up Rate N/A Bench Study
Final Safety Findings 1. Leachables assessment of MedStream infusion pumps at intervals of 4 months, 8 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months and 96 months
2. All results acceptable through 8 years.
Final Effect Findings . Leachables assessment of MedStream infusion pumps at intervals of 4 months, 8 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months and 96 months
2. All results acceptable through 8 years.
Study Strengths & Weaknesses N/A Bench Study
Recommendations for Labeling Changes No labeling change recommended.


Leachables Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/17/2011 07/15/2011 On Time
one year report 12/17/2011 12/15/2011 On Time
18 month report 06/16/2012 06/15/2012 On Time
two year report 12/16/2012 12/17/2012 Overdue/Received
three year report 12/16/2013 12/16/2013 On Time
four year report 12/16/2014 12/11/2014 On Time
five year report 12/16/2015 12/15/2015 On Time
six year report 12/15/2016 12/15/2016 On Time
seven year report 12/15/2017 12/15/2017 On Time
eight year report 12/15/2018 12/11/2018 On Time
nine year report 12/11/2019 12/11/2019 On Time
final report 12/16/2020 01/29/2021 Overdue/Received


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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