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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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AngelMed Guardian PAS


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General
Study Status Study Pending
Application Number P150009 / PAS001
Date Current Protocol Accepted  
Study Name AngelMed Guardian PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Positive predictive value (PPV) and false positive rate (FPR) will be examined. Prospective, non-randomized, single arm, event-based, multi-center trail to assess device diagnostic accuracy, physician compliance, implantation expertise, emergency department physician experience, patient compliance for alerts, and training for prescribing, implanting, and emergency physicians, as well as patients. New subjects will be enrolled and a past study will be used as a control.
Study Population Description Patients with prior ACS events and high risk for recurrent ACS events.
Sample Size A minimum of 500 patients for the purpose of accruing 314 adjudicated true positive or false positive events.
Data Collection Co-primary endpoints include determination of PPV and FPR. Secondary endpoints include additional information: frequency of alarm-only ACS events (no signs of symptoms/discomfort), and the amount of time between patient symptom reports and medical presentation.
Follow-up Visits and Length of Follow-up Completion of follow-up study is anticipated by March 2023.


AngelMed Guardian PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/08/2018 10/10/2018 Overdue/Received
one year report 04/09/2019 04/01/2019 On Time
18 month report 10/08/2019 10/01/2019 On Time
two year report 04/08/2020    
three year report 04/08/2021    
four year report 04/08/2022    


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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