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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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Mitral Model 11000M, Cont f/u Post-Approval Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P150048 S012/ PAS001
Date Original Protocol Accepted 11/05/2018
Date Current Protocol Accepted 11/05/2018
Study Name Mitral Model 11000M, Cont f/u Post-Approval Study
Device Name Edwards Pericardial Mitral Bioprosthesis, Model 11000M
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives The purpose of this study is to collect continued follow-up of the premarket cohort and characterize the long-term safety and effectiveness of the Edwards Pericardial Mitral Bioprothesis, Model 11000M
Study Population Study Population: Patients implanted with the Pericardial term Bioprothesis, Model 11000M. Indication: The Pericardial Aortic Bioprosthesis, Model 11000M, is indicated for the replacement of native or prosthetic mitral heart valves.
Sample Size 25 patients, 3 sites
Key Study Endpoints The primary safety endpoint is the rate of implanted subjects that experience structural deterioration of Model 11000M. The secondary safety endpoints evaluates the following: thromboembolism, valve thrombosis, all bleeding/hemorrhage, major bleeding/hemorrhage, all/major paravalvular leak, non-structural valve deterioration, endocarditis, all-cause mortality, trial valve-related mortality, trial valve-related reoperation, explant, and hemolysis
Follow-up Visits and Length of Follow-up 10 years


Mitral Model 11000M, Cont f/u Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 06/29/2019 09/10/2019 On Time
2 year report 06/29/2020 06/25/2020 On Time
3 year report 06/29/2021 06/25/2021 On Time
4 year report 06/29/2022 06/27/2022 On Time
5 year report 06/29/2023 06/26/2023 On Time
6 year report 06/28/2024    
7 year report 06/28/2025    
8 year report 06/29/2026    
9 year report 06/29/2027    


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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