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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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Cont F/u Low Risk Premarket Cohort

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Study Status Progress Adequate
Application Number P130021 S076/ PAS001
Date Current Protocol Accepted  
Study Name Cont F/u Low Risk Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of all 148 subjects who were enrolled in the Bicuspid Registry under IDE G160022. The objective of this study is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population Description All living subjects who were enrolled in the Bicuspid Registry.
Sample Size 148
Data Collection All-cause mortality, all stroke (disabling and nondisabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
Follow-up Visits and Length of Follow-up 10 years. All subjects are followed annually through 10 years post procedure.

Cont F/u Low Risk Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 03/31/2021 03/30/2021 On Time
2 year report 03/31/2022 03/23/2022 On Time
3 year report 03/31/2023    
4 year report 03/31/2024    
5 year report 03/31/2025    
6 year report 03/31/2026    
7 year report 03/31/2027    
8 year report 03/31/2028    
9 year report 03/31/2029    
10 year report 03/31/2030    

Contact Us

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

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