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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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Short-Mid-Term F/u of New COC36 patients

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Study Status Progress Inadequate
Application Number P070026 S004/ PAS002
Date Current Protocol Accepted 03/12/2015
Study Name Short-Mid-Term F/u of New COC36 patients
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21

Short-Mid-Term F/u of New COC36 patients Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/01/2013 10/01/2013 On Time
one year report 04/02/2014 04/02/2014 On Time
18 month report 10/01/2014 10/01/2014 On Time
two year report 04/02/2015 03/31/2015 On Time
quarterly report 10/24/2015 10/13/2015 On Time
quarterly report 01/24/2016 01/19/2016 On Time
three year report 04/01/2016 04/01/2016 On Time
quarterly report 07/20/2016 07/20/2016 On Time
Quarterly Report 10/18/2016 10/18/2016 On Time
quarterly report 01/23/2017 01/23/2017 On Time
clarifications to R29 Report 04/18/2017 04/18/2017 On Time
four year report 05/16/2017 05/17/2017 Overdue/Received
quarterly report 07/20/2017 07/20/2017 On Time
quarterly report 10/18/2017 10/18/2017 On Time
six year report 04/01/2018 03/30/2018 On Time
quarterly report 07/23/2018 07/23/2018 On Time
quarterly report 10/23/2018 09/11/2018 On Time
seven year report 04/01/2019    

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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