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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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MADIT-CRT ACC NCDR


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General
Study Status Progress Adequate
Application Number P010012 S230/ PAS001
Date Current Protocol Accepted 01/18/2013
Study Name MADIT-CRT ACC NCDR
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21


MADIT-CRT ACC NCDR Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/17/2011 03/16/2011 On Time
one year report 09/16/2011 09/14/2011 On Time
18 month report 03/16/2012 03/15/2012 On Time
two year report 09/15/2012 09/17/2012 Overdue/Received
three year report 01/31/2014 01/27/2014 On Time
four year report 01/31/2015 01/30/2015 On Time
five year report 01/31/2016 01/27/2016 On Time
six year report 01/31/2017 01/26/2017 On Time
seven year report 01/31/2018 01/30/2018 On Time
eight year report 01/31/2019 01/25/2019 On Time
nine year report 01/31/2020    


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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