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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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RWU of LOTUS Edge Valve System


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General
Study Status Protocol Pending
Application Number P180029 / PAS002
Study Name RWU of LOTUS Edge Valve System
General Study Protocol Parameters


RWU of LOTUS Edge Valve System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/22/2019 10/16/2019 On Time
one year report 04/22/2020    
18 month report 10/21/2020    
two year report 04/22/2021    
30 month report 10/21/2021    
three year report 04/22/2022    
four year report 04/22/2023    


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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