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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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OptiSure Lead Post Approval Study

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Study Status Progress Adequate
Application Number P950022 S085/ PAS001
Date Current Protocol Accepted 02/21/2014
Study Name OptiSure Lead Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs

OptiSure Lead Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/22/2014 08/25/2014 Overdue/Received
one year report 02/21/2015 02/20/2015 On Time
18 month report 08/22/2015 08/24/2015 Overdue/Received
two year report 02/21/2016 02/23/2016 Overdue/Received
three year report 03/21/2017 03/20/2017 On Time
four year report 03/20/2018 03/20/2018 On Time
five year report 03/20/2019 03/20/2019 On Time
six year report 03/20/2020    

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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