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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-Raindrop Near Vision Inlay New Enrollment


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General
Study Status Protocol Overdue
Application Number P150034 / PAS002
Study Name OSB Lead-Raindrop Near Vision Inlay New Enrollment
General Study Protocol Parameters


OSB Lead-Raindrop Near Vision Inlay New Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2016 01/23/2017 Overdue/Received
one year report 06/29/2017 06/28/2017 On Time
18 month report 12/28/2017    
two year report 06/29/2018    
three year report 06/29/2019    
four year report 06/28/2020    
five year report 06/28/2021    


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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