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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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ODE Lead-PAS Continued Follow-up


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General
Study Status Study Pending
Application Number P150048 / PAS001
Date Current Protocol Accepted 09/21/2017
Study Name ODE Lead-PAS Continued Follow-up
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, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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 Aortic Bioprosthesis, Model 11000A.
Study Population Description Study Population: Patients implanted with the Pericardial Aortic Bioprosthesis, Model 11000A. Indication: The Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of native or prosthetic aortic heart valves.
Sample Size 222 patients, 3 sites
Data Collection The primary safety endpoint is the rate of implanted subjects that experience structural deterioration of Model 11000A. 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


ODE Lead-PAS Continued Follow-up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2017    
one year report 06/29/2018    
18 month report 12/28/2018    
two year report 06/29/2019    
three year report 06/28/2020    
four year report 06/28/2021    


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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