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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Continued Follow-up of the Amulet IDE Cohort


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General
Study Status Study Pending
Application Number P200049 / PAS001
Date Current Protocol Accepted  
Study Name Continued Follow-up of the Amulet IDE Cohort
General Study Protocol Parameters


Continued Follow-up of the Amulet IDE Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/12/2022    
1 year report 08/14/2022    
18 month report 02/12/2023    
2 year report 08/14/2023    
3 year report 08/13/2024    
4 year report 08/13/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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