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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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REGAL and EMINENT Long Term f/u studies


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General
Study Status Progress Adequate
Application Number P180011 / PAS002
Date Current Protocol Accepted  
Study Name REGAL and EMINENT Long Term f/u studies
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System ; new enrollment European post market registry



Study Population Description All comers; Eluvia DES only
Sample Size 500 patients
Data Collection Health economics, technical/procedural success, MAEs, primary patency, CD-TLR
Follow-up Visits and Length of Follow-up 24 months


REGAL and EMINENT Long Term f/u studies Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/19/2019 03/18/2019 On Time
one year report 09/18/2019 09/16/2019 On Time
18 month report 03/18/2020    
two year report 09/17/2020    
three year report 09/17/2021    


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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