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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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ProMRI ICD Post-Approval Study

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Study Status Progress Adequate
Application Number P050023 S087/ PAS001
Date Current Protocol Accepted 07/21/2017
Study Name ProMRI ICD Post-Approval Study
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21

ProMRI ICD Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/20/2016 06/01/2016 On Time
one year report 12/20/2016 11/01/2016 On Time
18 month report 06/20/2017 05/02/2017 On Time
two year report 12/20/2017 11/02/2017 On Time
three year report 12/20/2018 05/01/2018 On Time
four year report 12/20/2019 01/11/2019 On Time
five year report 12/19/2020    
Final Report 11/02/2021    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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