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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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OSB Lead-TECNIS Symfony Toric New Enrollment Study

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Study Status Protocol Overdue
Application Number P980040 S065/ PAS001
Study Name OSB Lead-TECNIS Symfony Toric New Enrollment Study
General Study Protocol Parameters

OSB Lead-TECNIS Symfony Toric New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/13/2017 01/18/2017 Overdue/Received
one year report 07/15/2017 07/14/2017 On Time
18 month report 01/13/2018 01/17/2018 Overdue/Received
two year report 07/15/2018    
three year report 07/15/2019    
four year report 07/14/2020    
five year report 07/14/2021    

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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