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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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MPP QP-ExCELs Sub-Study PAS


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General
Study Status Progress Adequate
Application Number P050023 S107/ PAS001
Study Name MPP QP-ExCELs Sub-Study PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Interim Safety Information Number of study sites enrolled 8 Sites

Number of subjects enrolled 12 Subjects

Follow-up rate Two (2) out of the 12 enrolled subjects reached the 3-month follow-up window and completed the 3-month follow-up visit. Therefore, 100% follow-up rate at 3 months. None of the 12 subjects reached the 6-month follow-up window.

Summary of Interim Results No study data are available for testing the primary hypothesis and estimating the defined metrics for the secondary endpoints.

Strengths and Weaknesses Study strengths and weaknesses cannot be assessed with this report given the study duration and little study data available.



MPP QP-ExCELs Sub-Study PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/04/2017 11/02/2017 On Time
one year report 05/06/2018 05/04/2018 On Time
18 month report 11/04/2018 11/02/2018 On Time
two year report 05/06/2019    
three year report 05/05/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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