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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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RESOLUTE ONYX CTO Post-approval study

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Study Status Progress Adequate
Application Number P110013 S088/ PAS001
Date Current Protocol Accepted  
Study Name RESOLUTE ONYX CTO Post-approval study
General Study Protocol Parameters
Study Design Meta Analysis
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21

RESOLUTE ONYX CTO Post-approval study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/14/2019 06/13/2019 On Time
one year report 12/14/2019 12/12/2019 On Time
18 month report 06/13/2020    
two year report 12/13/2020    
three year report 12/13/2021    
four year report 12/13/2022    

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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